Clinical trial • Phase III • Oncology

DEXAMETHASONE for Multiple myeloma

Phase III trial of DEXAMETHASONE for Multiple myeloma.

Overview

Trial Therapeutic Area: Oncology
Trial Disease: Multiple myeloma
Trial Stage: Phase III
Drug Modality: Monoclonal antibody | Small molecule
Orphan Drug: Yes

Key dates

Initial CTIS Submission Date: 11-10-2024
First CTIS Authorization Date: 28-11-2024

Trial design

Randomised, open-label, arm a (control): lenalidomide and dexamethasone (revlimid 25 mg hard capsules [lenalidomide] + dexamethasone oral solution). arm b (experimental): daratumumab (darzalex 1800 mg solution for injection, subcutaneous) in combination with lenalidomide and dexamethasone. specific dosing: revlimid 25 mg (product name indicates 25 mg hard capsules), dexamethasone max daily amount listed as 20 mg; daratumumab product 1800 mg sc. exact schedule details are not fully specified in the part i summary; arm b described as daratumumab and lenalidomide and dexamethasone administered for 2 cycles in the arm description. Phase III trial in Belgium, France.

Randomised: Yes
Open Label: Yes
Comparator: Arm A (control): Lenalidomide and Dexamethasone (Revlimid 25 mg hard capsules [lenalidomide] + dexamethasone oral solution). Arm B (experimental): Daratumumab (DARZALEX 1800 mg solution for injection, subcutaneous) in combination with lenalidomide and dexamethasone. Specific dosing: Revlimid 25 mg (product name indicates 25 mg hard capsules), Dexamethasone max daily amount listed as 20 mg; Daratumumab product 1800 mg SC. Exact schedule details are not fully specified in the Part I summary; Arm B described as daratumumab and lenalidomide and dexamethasone administered for 2 cycles in the arm description.
Target Sample Size: 294

Stratification factors

ISS stage (measurable with β2-microglobulin and albumin)

Eligibility

Recruits 294 Vulnerable populations were not selected for inclusion. Each subject must sign an informed consent form. Subjects protected by a legal regime (guardianship, trusteeship) are excluded ("Refusal to consent or protected by legal regime ( guardianship, trusteeship)"). Consent is provided by the subject; no assent/child consent procedures are indicated..

Pregnancy Exclusion: A man who is sexually active with a woman of childbearing potential must agree to use a latex or synthetic condom, even if they had a successful vasectomy. All men must also not donate sperm during the study, for 4 weeks after the last dose of lenalidomid, and for 4 months after the last dose of daratumumab. Women participating in this study must be postmenopausal
Vulnerable Population: Vulnerable populations were not selected for inclusion. Each subject must sign an informed consent form. Subjects protected by a legal regime (guardianship, trusteeship) are excluded ("Refusal to consent or protected by legal regime ( guardianship, trusteeship)"). Consent is provided by the subject; no assent/child consent procedures are indicated.

Inclusion criteria

{"criterion_text":"- Subject must be at least 65 years of age"}
{"criterion_text":"- Subject must have documented multiple myeloma satisfying the CRAB riteria and measurable disease defined as: 1-Monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy proven plasmacytoma 2-Measurable disease as defined by any of the following: - IgG myeloma: Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL; or - IgA, IgM, IgD, or IgE multiple myeloma: serum M-protein level ≥0.5 g/dL ; or - Light chain multiple myeloma: Serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio (only measurable with freelite® by Binding site); or - Urine M-protein level ≥200 mg/24 hours"}
{"criterion_text":"- Newly diagnosed and not considered candidate for high-dose chemotherapy with SCT"}
{"criterion_text":"- Subject must have a Frailty Score ≥ 2"}
{"criterion_text":"- Subject must have within 5 days prior to first drug intake (C1D1) pretreatment clinical laboratory values meeting the following criteria during the Screening Phase: a) hemoglobin ≥7.5 g/dL (≥4.65 mmol/L; prior red blood cell [RBC] transfusion or recombinant human erythropoietin use is permitted); b) absolute neutrophil count ≥1.0 x 109/L (granulocyte colony stimulating factor [GCSF] use is permitted); c) platelet count ≥70 x 109/L for subjects in whom <50% of bone marrow nucleated cells are plasma cells; otherwise platelet count >50 × 109/L (transfusions are not permitted to achieve this minimum platelet count). d) aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN); e) alanine aminotransferase (ALT) ≤2.5 x ULN; f) total bilirubin ≤2.0 x ULN, except in subjects with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin ≤2.0 x ULN); g) creatinine clearance≥30mL/min(for lenalidomide dose adjustment for subjects with creatinine clearance 30-60 mL/min). Creatinine clearance may be calculated using the Cockcroft-Gault formula h) corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L)"}
{"criterion_text":"- Measurable ISS with β2-microglobulin and albumin values for randomization"}
{"criterion_text":"- A man who is sexually active with a woman of childbearing potential must agree to use a latex or synthetic condom, even if they had a successful vasectomy. All men must also not donate sperm during the study, for 4 weeks after the last dose of lenalidomid, and for 4 months after the last dose of daratumumab. Women participating in this study must be postmenopausal"}
{"criterion_text":"- Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICF"}
{"criterion_text":"- Subjects affiliated with an appropriate social security system"}

Exclusion criteria

{"criterion_text":"- Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma."}
{"criterion_text":"- Subject has a diagnosis of Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions."}
{"criterion_text":"- Subject has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course of corticosteroids before treatment."}
{"criterion_text":"- Subject has a history of malignancy within 5 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 5 years)."}
{"criterion_text":"- Subject has had radiation therapy within 14 days of randomization."}
{"criterion_text":"- Subject has had plasmapheresis within 28 days of randomization."}
{"criterion_text":"- Subject is exhibiting clinical signs of meningeal involvement of multiple myeloma."}
{"criterion_text":"- Subject has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume [FEV] in 1 second <60% of predicted normal), persistent asthma, or a history of asthma within the last 2 years (intermittent asthma is allowed). Subjects with known or suspected COPD or asthma must have a FEV1 test during screening."}
{"criterion_text":"- Subject is known to be seropositive for history of human immunodeficiency virus (HIV)"}
{"criterion_text":"- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR."}
{"criterion_text":"- (Known to be) seropositive for hepatitis C."}
{"criterion_text":"- Subject has any concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study."}
{"criterion_text":"- Subject has clinically significant cardiac disease, including: \tmyocardial infarction within 1 year before randomization, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV \tuncontrolled cardiac arrhythmia (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4 Grade ≥ 2) or clinically significant ECG abnormalities \tscreening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) >470 msec"}
{"criterion_text":"- Subject has known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure)."}
{"criterion_text":"- Subject has plasma cell leukemia (according to World Health Organization [WHO] criterion: ≥20% of cells in the peripheral blood with an absolute plasma cell count of more than 2 × 109/L) or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)."}
{"criterion_text":"- Subject is known or suspected of not being able to comply with the study protocol (eg, because of alcoholism, drug dependency, or psychological disorder). Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. Subject is taking any prohibited medications as per Section 8.3."}
{"criterion_text":"- Subject has had major surgery within 2 weeks before randomization or has not fully recovered from surgery."}
{"criterion_text":"- Subject has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before randomization or is currently enrolled in an interventional investigational study."}
{"criterion_text":"- Refusal to consent or protected by legal regime ( guardianship, trusteeship)"}
{"criterion_text":"- Subject has contraindications to required prophylaxis for deep vein thrombosis and pulmonary embolism"}
{"criterion_text":"- Incidence of gastrointestinal disease that may significantly alter the absorption of oral drugs."}
{"criterion_text":"- Subject has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course of corticosteroids before treatment."}

Endpoints

Primary endpoints

{"endpoint_text":"- The primary endpoint is PFS time, which is defined as the duration from the date of randomization to either progressive disease, or death, whichever occurs first. Disease progression will be determined according to the 2016 IMWG criteria.","definition_or_measurement_approach":"PFS time defined as duration from date of randomization to progressive disease or death; disease progression determined according to the 2016 IMWG criteria."}

Secondary endpoints

{"endpoint_text":"- Time-to-treatment failure, defined as time from randomization to discontinuation of therapy for any reason including death, progression, toxicity.","definition_or_measurement_approach":"Time from randomization to discontinuation of therapy for any reason including death, progression, toxicity."}
{"endpoint_text":"- Time to next treatment, defined as the time from randomization to the start of the next-line treatment.","definition_or_measurement_approach":"Time from randomization to start of next-line treatment."}
{"endpoint_text":"- PFS2 time, defined as the time from randomization to progression on the next line of treatment or death, whichever comes first. Disease progression will be based on investigator judgment. For those subjects who are still alive and not yet progressed on the next line of treatment, they will be censored on the last date of follow-up.","definition_or_measurement_approach":"Time from randomization to progression on the next line of treatment or death; progression based on investigator judgment; censoring rules described."}
{"endpoint_text":"- Overall survival (OS) time, measured from the date of randomization to the date of the subject's death. If the subject is alive or the vital status is unknown at last contact, then the subject's data will be censored at the date the subject was last known to be alive.","definition_or_measurement_approach":"Time from randomization to date of death; censor at last contact if alive or vital status unknown."}
{"endpoint_text":"- CR, defined as: - Negative immunofixation of serum and urine, and - Disappearance of any soft tissue plasmacytomas, and - < 5 % plasma cells (PCs) in bone marrow - For those IgG Kappa myeloma subjects with at least ≤2g/l M-protein on 2 consecutive visits, DIRA test will be utilized to confirm daratumumab interference and rule out false positive immunofixation. Patients who have confirmed daratumumab interference, but meet all other clinical criteria for CR, will be considered CR.","definition_or_measurement_approach":"CR defined by negative serum and urine immunofixation, disappearance of soft tissue plasmacytomas, and <5% plasma cells in bone marrow. DIRA test may be used to confirm daratumumab interference in specific cases."}
{"endpoint_text":"- VGPR or better, defined as VGPR or CR according to the IMWG criteria during or after the study treatment at the time of data cutoff.","definition_or_measurement_approach":"VGPR or CR per IMWG criteria during or after treatment."}
{"endpoint_text":"- Overall response, defined as CR or VGPR or PR, according to the IMWG criteria, during or after the study treatment.","definition_or_measurement_approach":"Overall response per IMWG criteria (CR, VGPR, PR)."}
{"endpoint_text":"- Collecting all AE (grade 3 or more) since the beginning of treatment until progression.","definition_or_measurement_approach":"All adverse events grade ≥3 collected from treatment start until progression (NCI-CTCAE V4.0)."}
{"endpoint_text":"- Evaluation of safety data by type, frequency, severity, relation to study drug, as well as changes in vital signs, physical examinations, incidence of treatment emergent adverse events (TEAEs), serious adverse events, abnormal laboratory test results (according to NCI-CTCAE V4.0).","definition_or_measurement_approach":"Safety evaluated by event type, frequency, severity, relation to study drug, vital signs, physical exams, TEAEs, SAEs, lab abnormalities per NCI-CTCAE V4.0."}
{"endpoint_text":"- Evaluation of quality of life based on EORTC C30, MY20 and EQ-5D questionnaires filled every 3 months from the C1J1 during the first year then every 6 months until the end of treatment for progression (then 8 and 16 weeks after the end of treatment).","definition_or_measurement_approach":"QoL measured by EORTC C30, MY20 and EQ-5D at scheduled intervals (every 3 months first year, then every 6 months, and specified post-treatment timepoints)."}
{"endpoint_text":"- MRD negativity, as measured at 12 months.","definition_or_measurement_approach":"MRD negativity measured at 12 months."}
{"endpoint_text":"- Event Free Survival, defined as time from randomization to discontinuation of therapy for any reason including death, progression or toxicity","definition_or_measurement_approach":"Time from randomization to discontinuation of therapy for any reason including death, progression or toxicity."}

Recruitment

Planned Sample Size: 294
Recruitment Window Months: 81
Consent Approach: Each subject must sign an informed consent form (ICF) indicating understanding of purpose and procedures and willingness to participate. Subject-level consent is required; subjects protected by guardianship/trusteeship are excluded. ICF addenda/documents exist in French and Dutch (L1_ICF_ADDENDUM_v5_FR, L1_ICF_ADDENDUM_v5_NL) and other addendum versions (v8, v9) are present; no child assent procedures are indicated (subjects are adults ≥65).

Geography

Total Number Of Sites: 86
Total Number Of Participants: 294

Belgium

Earliest CTIS Part Ii Submission Date: 25-10-2024
Latest Decision Or Authorization Date: 28-11-2024
Processing Time Days: 34
Number Of Sites: 7
Number Of Participants: 20

Sites

Site Name: Cliniques Universitaires Saint Luc
Department Name: hématologie
Principal Investigator Name: Marie-Christiane VEKEMANS
Principal Investigator Email: marie-christiane.vekemans@uclouvain.be
Contact Person Name: Marie-Christiane VEKEMANS
Contact Person Email: marie-christiane.vekemans@uclouvain.be

Site Name: Centre Hospitalier Universitaire De Liege
Department Name: hématologie
Principal Investigator Name: Bernard DE PRIJCK
Principal Investigator Email: bernard.deprijck@chu.ulg.ac.be
Contact Person Name: Bernard DE PRIJCK
Contact Person Email: bernard.deprijck@chu.ulg.ac.be

Site Name: Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name: hématologie
Principal Investigator Name: Julien DEPAUS
Principal Investigator Email: julien.depaus@chuuclnamur.uclouvain.be
Contact Person Name: Julien DEPAUS
Contact Person Email: julien.depaus@chuuclnamur.uclouvain.be

Site Name: Institut Jules Bordet
Department Name: hématologie
Principal Investigator Name: Nathalie MEULEMAN
Principal Investigator Email: nathalie.meuleman@bordet.be
Contact Person Name: Nathalie MEULEMAN
Contact Person Email: nathalie.meuleman@bordet.be

Site Name: Grand Hopital De Charleroi
Department Name: hématologie
Principal Investigator Name: Géraldine VERSTRAETE
Principal Investigator Email: Geraldine.VERSTRAETE@ghdc.be
Contact Person Name: Géraldine VERSTRAETE
Contact Person Email: Geraldine.VERSTRAETE@ghdc.be

Site Name: UZ Brussel
Department Name: hématologie
Principal Investigator Name: Rik SCHOTS
Principal Investigator Email: rik.schots@uzbrussel.be
Contact Person Name: Rik SCHOTS
Contact Person Email: rik.schots@uzbrussel.be

Site Name: Katholieke Universiteit te Leuven
Department Name: hématologie
Principal Investigator Name: Michel DELFORGE
Principal Investigator Email: michel.delforge@uzleuven.be
Contact Person Name: Michel DELFORGE
Contact Person Email: michel.delforge@uzleuven.be

France

Earliest CTIS Part Ii Submission Date: 08-11-2024
Latest Decision Or Authorization Date: 29-11-2024
Processing Time Days: 21
Number Of Sites: 79
Number Of Participants: 274

Sites

Site Name: Centre Hospitalier De Perigueux
Department Name: Onco-hématologie
Principal Investigator Name: Claire CALMETTES
Principal Investigator Email: claire.calmettes@ch-perigueux.fr
Contact Person Name: Claire CALMETTES
Contact Person Email: claire.calmettes@ch-perigueux.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: unité d'hématologie lymphoïdes
Principal Investigator Name: Karim BELHADJ
Principal Investigator Email: karim.belhadj@hmn.aphp.fr
Contact Person Name: Karim BELHADJ
Contact Person Email: karim.belhadj@hmn.aphp.fr

Site Name: Centre Hospitalier Victor Dupouy
Department Name: hématologie
Principal Investigator Name: Driss CHAOUI
Principal Investigator Email: driss.chaoui@ch-argenteuil.fr
Contact Person Name: Driss CHAOUI
Contact Person Email: driss.chaoui@ch-argenteuil.fr

Site Name: Centre Henri Becquerel
Department Name: Centre de lutte contre le cancer
Principal Investigator Name: Pascal LENAIN
Principal Investigator Email: pascal.lenain@chb.unicancer.fr
Contact Person Name: Pascal LENAIN
Contact Person Email: pascal.lenain@chb.unicancer.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: hématologie
Principal Investigator Name: Bruno ROYER
Principal Investigator Email: bruno.royer@aphp.fr
Contact Person Name: Bruno ROYER
Contact Person Email: bruno.royer@aphp.fr

Site Name: Centre Hospitalier De Libourne Robert Boulin
Department Name: hématologie
Principal Investigator Name: Didier ADIKO
Principal Investigator Email: didier.adiko@ch-libourne.fr
Contact Person Name: Didier ADIKO
Contact Person Email: didier.adiko@ch-libourne.fr

Site Name: Centre Hospitalier Bretagne Atlantique
Department Name: Médecine Interne
Principal Investigator Name: Pascal GODMER
Principal Investigator Email: pascal.godmer@ch-bretagne-atlantique.fr
Contact Person Name: Pascal GODMER
Contact Person Email: pascal.godmer@ch-bretagne-atlantique.fr

Site Name: Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
Department Name: hématologie
Principal Investigator Name: Emmanuel FLECK
Principal Investigator Email: emmanuel.fleck@ch-larochelle.fr
Contact Person Name: Emmanuel FLECK
Contact Person Email: emmanuel.fleck@ch-larochelle.fr

Site Name: Centre Hospitalier Universitaire De Montpellier
Department Name: hématologie
Principal Investigator Name: Laure VINCENT
Principal Investigator Email: l-vincent@chu-montpellier.fr
Contact Person Name: Laure VINCENT
Contact Person Email: l-vincent@chu-montpellier.fr

Site Name: Centre Hospitalier Universitaire Grenoble Alpes
Department Name: hématologie
Principal Investigator Name: Clara MARIETTE
Principal Investigator Email: CMariette@chu-grenoble.fr
Contact Person Name: Clara MARIETTE
Contact Person Email: CMariette@chu-grenoble.fr

Site Name: Centre Hospitalier Universitaire D Orleans
Department Name: hématologie
Principal Investigator Name: Omar BENBRAHIM
Principal Investigator Email: omar.benbrahim@chr-orleans.fr
Contact Person Name: Omar BENBRAHIM
Contact Person Email: omar.benbrahim@chr-orleans.fr

Site Name: Les Hopitaux Universitaires De Strasbourg
Department Name: Onco-hématologie
Principal Investigator Name: Cécile FOHRER-SONNTAG
Principal Investigator Email: c.sonntag@icans.eu
Contact Person Name: Cécile FOHRER-SONNTAG
Contact Person Email: c.sonntag@icans.eu

Site Name: Centre Hospitalier Regional Universitaire De Tours
Department Name: hématologie
Principal Investigator Name: Lotfi BENBOUBKER
Principal Investigator Email: l.benboubker@chu-tours.fr
Contact Person Name: Lotfi BENBOUBKER
Contact Person Email: l.benboubker@chu-tours.fr

Site Name: Centre Hospitalier Intercommunal De Cornouaille
Department Name: Médecine Interne
Principal Investigator Name: Ronan LE CALLOCH
Principal Investigator Email: r.lecalloch@ch-cornouaille.fr
Contact Person Name: Ronan LE CALLOCH
Contact Person Email: r.lecalloch@ch-cornouaille.fr

Site Name: Centre Hospitalier Universitaire De Rennes
Department Name: hématologie clinique
Principal Investigator Name: Olivier DECAUX
Principal Investigator Email: olivier.decaux@chu-rennes.fr
Contact Person Name: Olivier DECAUX
Contact Person Email: olivier.decaux@chu-rennes.fr

Site Name: Centre Hospitalier Annecy Genevois
Department Name: hématologie
Principal Investigator Name: Frédérique ORSINI PIOCELLE
Principal Investigator Email: forsinipiocelle@ch-annecygenevois.fr
Contact Person Name: Frédérique ORSINI PIOCELLE
Contact Person Email: forsinipiocelle@ch-annecygenevois.fr

Site Name: Groupe Hospitalier Saint Vincent
Department Name: oncologie
Principal Investigator Name: fréderic MALOISEL
Principal Investigator Email: f.maloisel@solcrr.org
Contact Person Name: fréderic MALOISEL
Contact Person Email: f.maloisel@solcrr.org

Site Name: Centre Hospitalier Yves Le Foll
Department Name: hématologie
Principal Investigator Name: Olivier ALLANGBA
Principal Investigator Email: olivier.allangba@ch-stbrieuc.fr
Contact Person Name: Olivier ALLANGBA
Contact Person Email: olivier.allangba@ch-stbrieuc.fr

Site Name: Centre Hospitalier De Perpignan
Department Name: hématologie clinique
Principal Investigator Name: Laurence SANHES
Principal Investigator Email: laurence.sanhes@ch-perpignan.fr
Contact Person Name: Laurence SANHES
Contact Person Email: laurence.sanhes@ch-perpignan.fr

Site Name: Hopital NOVO
Department Name: hématologie et thérapie cellulaire
Principal Investigator Name: Riad BENRAMDANE
Principal Investigator Email: riad.benramdane@ght-novo.fr
Contact Person Name: Riad BENRAMDANE
Contact Person Email: riad.benramdane@ght-novo.fr

Site Name: Institut Curie
Department Name: Onco-hématologie
Principal Investigator Name: Frédérique KUHNOWSKI
Principal Investigator Email: frederique.kuhnowski@curie.fr
Contact Person Name: Frédérique KUHNOWSKI
Contact Person Email: frederique.kuhnowski@curie.fr

Site Name: Centre Hospitalier De Versailles
Department Name: Onco-hématologie
Principal Investigator Name: Sophie RIGAUDEAU
Principal Investigator Email: srigaudeau@ght78sud.fr
Contact Person Name: Sophie RIGAUDEAU
Contact Person Email: srigaudeau@ght78sud.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: hématologie
Principal Investigator Name: Laurent GARDERET
Principal Investigator Email: laurent.garderet@aphp.fr
Contact Person Name: Laurent GARDERET
Contact Person Email: laurent.garderet@aphp.fr

Site Name: Bicetre Hospital
Department Name: Rhumatologie
Principal Investigator Name: Rakiba BELKHIR
Principal Investigator Email: rakiba.belkhir@aphp.fr
Contact Person Name: Rakiba BELKHIR
Contact Person Email: rakiba.belkhir@aphp.fr

Site Name: Centre Hospitalier Valence
Department Name: hématologie et oncologie médicale
Principal Investigator Name: Pascal BOURQUARD
Principal Investigator Email: pbourquard@ch-valence.fr
Contact Person Name: Pascal BOURQUARD
Contact Person Email: pbourquard@ch-valence.fr

Site Name: Centre Hospitalier Universitaire De Bordeaux
Department Name: hématologie et thérapie cellulaire
Principal Investigator Name: Cyrille HULIN
Principal Investigator Email: cyrille.hulin@chu-bordeaux.fr
Contact Person Name: Cyrille HULIN
Contact Person Email: cyrille.hulin@chu-bordeaux.fr

Site Name: Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources
Department Name: hématologie
Principal Investigator Name: Reza TABRIZI
Principal Investigator Email: reza.tabrizi@ch-mdm.fr
Contact Person Name: Reza TABRIZI
Contact Person Email: reza.tabrizi@ch-mdm.fr

Site Name: Groupe Hospitalier Bretagne Sud
Department Name: hématologie
Principal Investigator Name: Adrien TREBOUET
Principal Investigator Email: a.trebouet@ghbs.bzh
Contact Person Name: Adrien TREBOUET
Contact Person Email: a.trebouet@ghbs.bzh

Site Name: Centre Hospitalier Universitaire De Caen Normandie
Department Name: hématologie clinique
Principal Investigator Name: Margaret MACRO
Principal Investigator Email: macro-m@chu-caen.fr
Contact Person Name: Margaret MACRO
Contact Person Email: macro-m@chu-caen.fr

Site Name: Centre Hospitalier Universitaire De Nimes
Department Name: hématologie clinique
Principal Investigator Name: Stefan WICKENHAUSER
Principal Investigator Email: drc@chu-nimes.fr
Contact Person Name: Stefan WICKENHAUSER
Contact Person Email: drc@chu-nimes.fr

Site Name: Centre Hospitalier Universitaire Amiens Picardie
Department Name: hématologie et thérapie cellulaire
Principal Investigator Name: Lydia MONTES
Principal Investigator Email: montes.lydia@chu-amiens.fr
Contact Person Name: Lydia MONTES
Contact Person Email: montes.lydia@chu-amiens.fr

Site Name: Oncopole Claudius Regaud
Department Name: hématologie
Principal Investigator Name: Aurore PERROT
Principal Investigator Email: perrot.aurore@iuct-oncopole.fr
Contact Person Name: Aurore PERROT
Contact Person Email: perrot.aurore@iuct-oncopole.fr

Site Name: Centre Hospitalier Universitaire De Saint Etienne
Department Name: hématologie
Principal Investigator Name: Emilie CHALAYER
Principal Investigator Email: emilie.chalayer@chu-st-etienne.fr
Contact Person Name: Emilie CHALAYER
Contact Person Email: emilie.chalayer@chu-st-etienne.fr

Site Name: Chorale Du Centre Hospitalier De Lens
Department Name: hématologie
Principal Investigator Name: Daniela ROBU
Principal Investigator Email: drobu@ch-lens.fr
Contact Person Name: Daniela ROBU
Contact Person Email: drobu@ch-lens.fr

Site Name: Centre Hospitalier Universitaire De Lille
Department Name: Maladies du sang
Principal Investigator Name: Thierry FACON
Principal Investigator Email: thierry.facon@chu-lille.fr
Contact Person Name: Thierry FACON
Contact Person Email: thierry.facon@chu-lille.fr

Site Name: Centre Hospitalier Sud Francilien
Department Name: hématologie clinique
Principal Investigator Name: Bertrand JOLY
Principal Investigator Email: unite.rechercheclinique@chsf.fr
Contact Person Name: Bertrand JOLY
Contact Person Email: unite.rechercheclinique@chsf.fr

Site Name: L’Hopital Alexandra Lepeve
Department Name: hématologie
Principal Investigator Name: Hélène DEMARQUETTE
Principal Investigator Email: helene.demarquette@ch-dunkerque.fr
Contact Person Name: Hélène DEMARQUETTE
Contact Person Email: helene.demarquette@ch-dunkerque.fr

Site Name: Centre Hospitalier Blois Simone Veil
Department Name: hématologie clinique
Principal Investigator Name: Abderazzak EL YAMANI
Principal Investigator Email: elyamaa@ch-blois.fr
Contact Person Name: Abderazzak EL YAMANI
Contact Person Email: elyamaa@ch-blois.fr

Site Name: Centre Hospitalier Universitaire De Nantes
Department Name: hématologie
Principal Investigator Name: Cyrille TOUZEAU
Principal Investigator Email: cyrille.touzeau@chu-nantes.fr
Contact Person Name: Cyrille TOUZEAU
Contact Person Email: cyrille.touzeau@chu-nantes.fr

Site Name: Centre Hospitalier De Roubaix
Department Name: hématologie clinique
Principal Investigator Name: Isabelle DERVITE
Principal Investigator Email: isabelle.dervite@ch-roubaix.fr
Contact Person Name: Isabelle DERVITE
Contact Person Email: isabelle.dervite@ch-roubaix.fr

Site Name: Centre Hospitalier Universitaire De Dijon
Department Name: hématologie clinique
Principal Investigator Name: Jean-Noël BASTIE
Principal Investigator Email: jean-noel.bastie@chu-dijon.fr
Contact Person Name: Jean-Noël BASTIE
Contact Person Email: jean-noel.bastie@chu-dijon.fr

Site Name: Les Hopitaux De Chartres
Department Name: Onco-hématologie
Principal Investigator Name: Adrienne De Labarthe
Principal Investigator Email: adelabarthe@ch-chartres.fr
Contact Person Name: Adrienne De Labarthe
Contact Person Email: adelabarthe@ch-chartres.fr

Site Name: Hopital Saint Antoine
Department Name: hématologie
Principal Investigator Name: Mohamad MOHTY
Principal Investigator Email: mohamad.mohty@inserm.fr
Contact Person Name: Mohamad MOHTY
Contact Person Email: mohamad.mohty@inserm.fr

Site Name: Centre Hospitalier Regional Et Universitaire De Brest
Department Name: hématologie clinique
Principal Investigator Name: Jean-Richard EVEILLARD
Principal Investigator Email: jean-richard.eveillard@chu-brest.fr
Contact Person Name: Jean-Richard EVEILLARD
Contact Person Email: jean-richard.eveillard@chu-brest.fr

Site Name: Hopital Prive Sevigne
Department Name: hématologie
Principal Investigator Name: Benoit BARREAU
Principal Investigator Email: benoit.bareau@gmail.com
Contact Person Name: Benoit BARREAU
Contact Person Email: benoit.bareau@gmail.com

Site Name: Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Department Name: hématologie
Principal Investigator Name: Muriel NEWINGER-PORTE
Principal Investigator Email: muriel.newinger@ghrmsa.fr
Contact Person Name: Muriel NEWINGER-PORTE
Contact Person Email: muriel.newinger@ghrmsa.fr

Site Name: CHU Besancon
Department Name: hématologie
Principal Investigator Name: Jean FONTAN
Principal Investigator Email: jfontan@chu-besancon.fr
Contact Person Name: Jean FONTAN
Contact Person Email: jfontan@chu-besancon.fr

Site Name: Grand Hopital De L Est Francilien
Department Name: hématologie et thérapie cellulaire
Principal Investigator Name: Wajed ABARAH
Principal Investigator Email: wabarah@ghef.fr
Contact Person Name: Wajed ABARAH
Contact Person Email: wabarah@ghef.fr

Site Name: Centre Hospitalier Et Universitaire De Limoges
Department Name: hématologie et thérapie cellulaire
Principal Investigator Name: Arnaud JACCARD
Principal Investigator Email: arnaud.jaccard@chu-limoges.fr
Contact Person Name: Arnaud JACCARD
Contact Person Email: arnaud.jaccard@chu-limoges.fr

Site Name: Centre Hospitalier De Bourg-En-Bresse
Department Name: Onco-hématologie
Principal Investigator Name: Sophie DUPIRE
Principal Investigator Email: recherche-clinique@ch-bourg01.fr
Contact Person Name: Sophie DUPIRE
Contact Person Email: recherche-clinique@ch-bourg01.fr

Site Name: CHRU De Nancy
Department Name: hématologie clinique
Principal Investigator Name: Lauriane CLEMENT-FILLIATRE
Principal Investigator Email: la.clement@chru-nancy.fr
Contact Person Name: Lauriane CLEMENT-FILLIATRE
Contact Person Email: la.clement@chru-nancy.fr

Site Name: CHU Gabriel-Montpied
Department Name: hématologie
Principal Investigator Name: Richard LEMAL
Principal Investigator Email: rlemal@chu-clermontferrand.fr
Contact Person Name: Richard LEMAL
Contact Person Email: rlemal@chu-clermontferrand.fr

Site Name: Centre Hospitalier Universitaire D'Angers
Department Name: Maladies du sang
Principal Investigator Name: Mamoun DIB
Principal Investigator Email: madib@chu-angers.fr
Contact Person Name: Mamoun DIB
Contact Person Email: madib@chu-angers.fr

Site Name: Centre Hospitalier Universitaire De Poitiers
Department Name: Onco-hématologie
Principal Investigator Name: Xavier LELEU
Principal Investigator Email: xavier.leleu@chu-poitiers.fr
Contact Person Name: Xavier LELEU
Contact Person Email: xavier.leleu@chu-poitiers.fr

Site Name: Clinique Victor Hugo
Department Name: Onco-hématologie
Principal Investigator Name: Eric VOOG
Principal Investigator Email: e.voog@cjb72.org
Contact Person Name: Eric VOOG
Contact Person Email: e.voog@cjb72.org

Site Name: Groupe Hospitalier Rance Emeraude
Department Name: Onco-hématologie
Principal Investigator Name: Alexia THANNBERGER
Principal Investigator Email: a.thannberger@ch-stmalo.fr
Contact Person Name: Alexia THANNBERGER
Contact Person Email: a.thannberger@ch-stmalo.fr

Site Name: Centre De Recherche En Cancerologie De Lyon
Department Name: Onco-hématologie
Principal Investigator Name: Philippe REY
Principal Investigator Email: philippe.rey@lyon.unicancer.fr
Contact Person Name: Philippe REY
Contact Person Email: philippe.rey@lyon.unicancer.fr

Site Name: Centre Hospitalier Universitaire Reims
Department Name: hématologie clinique
Principal Investigator Name: Sophie GODET
Principal Investigator Email: sophie.godet@chu-reims.fr
Contact Person Name: Sophie GODET
Contact Person Email: sophie.godet@chu-reims.fr

Site Name: Institut Bergonie
Department Name: hématologie
Principal Investigator Name: Anna SCHMITT
Principal Investigator Email: a.schmitt@bordeaux.unicancer.fr
Contact Person Name: Anna SCHMITT
Contact Person Email: a.schmitt@bordeaux.unicancer.fr

Site Name: Centre Hospital Region Metz Thionville
Department Name: hématologie
Principal Investigator Name: Véronique DORVAUX
Principal Investigator Email: v.dorvaux@chr-metz-thionville.fr
Contact Person Name: Véronique DORVAUX
Contact Person Email: v.dorvaux@chr-metz-thionville.fr

Site Name: Institut Paoli Calmettes
Department Name: hématologie
Principal Investigator Name: Jean-marc SCHIANO DE COLELLA
Principal Investigator Email: schianojm@ipc.unicancer.fr
Contact Person Name: Jean-marc SCHIANO DE COLELLA
Contact Person Email: schianojm@ipc.unicancer.fr

Site Name: Centre Hospitalier Pierre Oudot
Department Name: hématologie
Principal Investigator Name: Florence LACHENAL
Principal Investigator Email: flachenal@ghnd.fr
Contact Person Name: Florence LACHENAL
Contact Person Email: flachenal@ghnd.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: hématologie clinique
Principal Investigator Name: Marie LE CANN
Principal Investigator Email: marie.lecann@aphp.fr
Contact Person Name: Marie LE CANN
Contact Person Email: marie.lecann@aphp.fr

Site Name: Clinique Victor Hugo (Centre De Cancerologie De La Sarthe)
Department Name: Onco-hématologie
Principal Investigator Name: Kamel LARIBI
Principal Investigator Email: klaribi@ch-lemans.fr
Contact Person Name: Kamel LARIBI
Contact Person Email: klaribi@ch-lemans.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: hématologie
Principal Investigator Name: Sabine BRECHIGNAC
Principal Investigator Email: sabine.brechignac@aphp.fr
Contact Person Name: Sabine BRECHIGNAC
Contact Person Email: sabine.brechignac@aphp.fr

Site Name: Centre Hospitalier D Avignon
Department Name: Onco-hématologie
Principal Investigator Name: Borhane SLAMA
Principal Investigator Email: bslama@ch-avignon.fr
Contact Person Name: Borhane SLAMA
Contact Person Email: bslama@ch-avignon.fr

Site Name: Centre Hospitalier Universitaire De Nice
Department Name: hématologie
Principal Investigator Name: Valentine RICHEZ
Principal Investigator Email: richez.v@chu-nice.fr
Contact Person Name: Valentine RICHEZ
Contact Person Email: richez.v@chu-nice.fr

Site Name: Polyclinique Bordeaux Nord Aquitaine
Department Name: Radiothérapie
Principal Investigator Name: Olivier FITOUSSI
Principal Investigator Email: o.fitoussi@bordeauxnord.com
Contact Person Name: Olivier FITOUSSI
Contact Person Email: o.fitoussi@bordeauxnord.com

Site Name: Groupe Hospitalier Du Havre
Department Name: Rhumatologie
Principal Investigator Name: Pierre LEBRETON
Principal Investigator Email: pierre.lebreton@ch-havre.fr
Contact Person Name: Pierre LEBRETON
Contact Person Email: pierre.lebreton@ch-havre.fr

Site Name: Centre Hospitalier Departemental Vendee
Department Name: Onco-hématologie
Principal Investigator Name: Mourad TIAB
Principal Investigator Email: mourad.tiab@chd-vendee.fr
Contact Person Name: Mourad TIAB
Contact Person Email: mourad.tiab@chd-vendee.fr

Site Name: Centre Hospitalier Metropole Savoie
Department Name: hématologie
Principal Investigator Name: Gian Matteo PICA
Principal Investigator Email: gian-matteo.pica@ch-metropole-savoie.fr
Contact Person Name: Gian Matteo PICA
Contact Person Email: gian-matteo.pica@ch-metropole-savoie.fr

Site Name: Hospices Civils De Lyon
Department Name: hématologie clinique
Principal Investigator Name: Lionel KARLIN
Principal Investigator Email: lionel.karlin@chu-lyon.fr
Contact Person Name: Lionel KARLIN
Contact Person Email: lionel.karlin@chu-lyon.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: hématologie
Principal Investigator Name: Marguerite VIGNON
Principal Investigator Email: marguerite.vignon@aphp.fr
Contact Person Name: Marguerite VIGNON
Contact Person Email: marguerite.vignon@aphp.fr

Site Name: Centre Hospitalier De La Cote Basque
Department Name: hématologie
Principal Investigator Name: Julie GAY
Principal Investigator Email: jgay@ch-cotebasque.fr
Contact Person Name: Julie GAY
Contact Person Email: jgay@ch-cotebasque.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: hématologie
Principal Investigator Name: Laurent FRENZEL
Principal Investigator Email: laurent.frenzel@aphp.fr
Contact Person Name: Laurent FRENZEL
Contact Person Email: laurent.frenzel@aphp.fr

Site Name: Centre Hospitalier William Morey
Department Name: Onco-hématologie
Principal Investigator Name: Céline KENNEL
Principal Investigator Email: celine.kennel@ch-chalon71.fr
Contact Person Name: Céline KENNEL
Contact Person Email: celine.kennel@ch-chalon71.fr

Site Name: Hopital D'Instruction Des Armees Percy
Department Name: hématologie
Principal Investigator Name: Jean-Valère MALFUSON
Principal Investigator Email: jvmalf@free.fr
Contact Person Name: Jean-Valère MALFUSON
Contact Person Email: jvmalf@free.fr

Site Name: Centre Hospitalier De Saint-Quentin
Department Name: Onco-hématologie
Principal Investigator Name: Rda GARIDI
Principal Investigator Email: r.garidi@ch-stquentin.fr
Contact Person Name: Rda GARIDI
Contact Person Email: r.garidi@ch-stquentin.fr

Site Name: Groupement Des Hopitaux De L'Institut Catholique De Lille
Department Name: Onco-hématologie
Principal Investigator Name: Emmanuelle BOURGEOIS
Principal Investigator Email: Bourgeois.Emmanuelle@ghicl.net
Contact Person Name: Emmanuelle BOURGEOIS
Contact Person Email: Bourgeois.Emmanuelle@ghicl.net

Sponsor

Primary sponsor

Full Name: Centre Hospitalier Universitaire De Lille
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: France

Third parties

{"country":"","full_name":"Janssen Pharmaceutica NV","duties_or_roles":"Source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name: DEXAMETHASONE
Active Substance: DEXAMETHASONE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Starting Dose: 20 mg
Dose Levels: 20 mg
Maximum Dose: 20 mg

Investigational Product Name: DARZALEX 1800 mg solution for injection
Active Substance: DARATUMUMAB
Modality: Monoclonal antibody
Routes Of Administration: SUBCUTANEOUS INJECTION
Route: SUBCUTANEOUS INJECTION
Authorisation Status: EU/1/16/1101/004
Orphan Designation: Yes
Starting Dose: 1800 mg
Dose Levels: 1800 mg
Maximum Dose: 1800 mg

Investigational Product Name: Revlimid 25 mg hard capsules
Active Substance: LENALIDOMIDE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL
Authorisation Status: EU/1/07/391/004
Starting Dose: 25 mg
Dose Levels: 25 mg
Maximum Dose: 25 mg

Combination Treatment: Yes

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