Clinical trial • Phase III • Oncology

BETAMETHASONE SODIUM PHOSPHATE for Multiple myeloma | Relapsed multiple myeloma

Phase III trial of BETAMETHASONE SODIUM PHOSPHATE for Multiple myeloma | Relapsed multiple myeloma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Multiple myeloma | Relapsed multiple myeloma
Trial Stage
Phase III
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
15-10-2024
First CTIS Authorization Date
29-11-2024

Trial design

Randomised, open-label, experimental arm: fixed duration (24 months) daratumumab + lenalidomide + dexamethasone (dara-len-dex) administered for a fixed duration of 24 months; control arm: continuous administration of daratumumab + lenalidomide + dexamethasone until disease progression. reported product dosing in part i: darzalex 1800 mg solution for injection (sc), daratumumab formulations (including iv, mg/kg), lenalidomide (up to 25 mg daily oral), dexamethasone (up to 40 mg oral/iv) (as listed in product entries). Phase III trial in France.

Randomised
Yes
Open Label
Yes
Comparator
Experimental arm: fixed duration (24 months) Daratumumab + Lenalidomide + Dexamethasone (Dara-Len-Dex) administered for a fixed duration of 24 months; Control arm: continuous administration of Daratumumab + Lenalidomide + Dexamethasone until disease progression. Reported product dosing in Part I: DARZALEX 1800 mg solution for injection (SC), daratumumab formulations (including IV, mg/kg), lenalidomide (up to 25 mg daily oral), dexamethasone (up to 40 mg oral/IV) (as listed in product entries).
Target Sample Size
477
Trial Duration For Participant
1460

Eligibility

Recruits 477 No vulnerable populations selected; trial enrols adults (≥ 18 years). Signed informed consent required. No assent process described..

Pregnancy Exclusion
Pregnancy or lactaction women
Vulnerable Population
No vulnerable populations selected; trial enrols adults (≥ 18 years). Signed informed consent required. No assent process described.

Inclusion criteria

  • {"criterion_text":"- Adult patients (≥ 18 years old)"}
  • {"criterion_text":"- Effective method of contraception for the duration of treatment and 3 months after the last dose for women of childbearing age and men with a partner of childbearing age :Progestin-only pill associated with inhibition of ovulation, Hormonal methods of contraception, including oral contraceptive pills containing a combination of estrogen + progesterone, vaginal ring, injectables, implants and intrauterine devices (IUDs), non-hormonal IUD, Bilateral tubal occlusion, Vasectomized partner with documented azoospermia 90 days after procedure and who received a medical assessment of surgical success, Intrauterine hormone release system (IUS), Complete abstinence : complete abstinence is defined as the complete avoidance of heterosexual intercourse. Complete abstinence is an acceptable form of contraception for all study drugs and must be used throughout the duration of the study and for the duration of time as specified above. It is not necessary to use any other method of contraception when complete abstinence is elected. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence"}
  • {"criterion_text":"- Documented MM in relapse according to standard criteria and requiring initiation of a first line salvage therapy."}
  • {"criterion_text":"- Subject must have measurable disease as defined by any of the following :• IgG myeloma : serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dL or urine M-protein level ≥ 200 mg/24 hours or • IgA, IgM, IgD, or IgE multiple myeloma : serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or • Light chain multiple myeloma : serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio."}
  • {"criterion_text":"- Subject must have received one prior line of therapy for MM"}
  • {"criterion_text":"- Subject must have achieved a response (PR or better) to the prior regimen."}
  • {"criterion_text":"- Subject must have an ECOG Performance Status score of 0, 1, or 2."}
  • {"criterion_text":"- For subjects experiencing toxicities resulting from previous therapy (including peripheral neuropathy),the toxicities must have been resolved or stabilized."}
  • {"criterion_text":"- Signed informed consent"}
  • {"criterion_text":"- Affiliation to a social security system or equivalent (recipient or assign)"}

Exclusion criteria

  • {"criterion_text":"- Evidence of refractoriness or intolerance to lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). If previously treated with a lenalidomide or daratumumab-containing regimen, the subject is excluded if he or she :Discontinued due to any severe adverse event related to prior lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) treatment, or If, at any time point, the subject was refractory to any dose of lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). Refractoriness to lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) is defined either as : Subjects whose disease progressed within 60 days of lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) administration; or o Subjects whose disease is nonresponsive while on lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). Nonresponsive disease is defined as either failure to achieve at least a minimal response or development of progressive disease while on lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody)."}
  • {"criterion_text":"- Subject is known to be seropositive for human immunodeficiency virus (HIV), hepatitis B (included history of previous infection) or hepatitis C."}
  • {"criterion_text":"- Creatinine clearance ≤30 mL/min (MDRD method) (lenalidomide dose adjustment will be considered for subjects with creatinine clearance 30-60 mL/min)."}
  • {"criterion_text":"- Hypersensitivity to the active substance or to any of the excipients"}
  • {"criterion_text":"- Pregnancy or lactaction women"}
  • {"criterion_text":"- Subject has received an allogenic stem cell transplant (regardless of timing)."}
  • {"criterion_text":"- Subjects planning to undergo a stem cell transplant prior to progression of disease on this study, ie, these subjects should not be enrolled in order to reduce disease burden prior to transplant"}
  • {"criterion_text":"- Subject has a history of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence within 3 years)."}
  • {"criterion_text":"- Subject has known MM meningeal involvement."}
  • {"criterion_text":"- Subject has plasma cell leukemia (>2.0 × 109/L circulating plasma cells by standard differential) or Waldenström’s macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis."}
  • {"criterion_text":"- Subject has any concurrent medical condition or disease (eg, active systemic infection) that is likely to interfere with 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 known uncontrolled chronic obstructive pulmonary disease (COPD)"}
  • {"criterion_text":"- Subject has clinically significant cardiac disease"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival (OS) at 4 years after randomization and initiation of salvage therapy.","definition_or_measurement_approach":"Overall survival measured at 4 years after randomization and initiation of salvage therapy (OS at 4 years)."}

Secondary endpoints

  • {"endpoint_text":"- Response rate according to the IMWG criteria (Durie BG, et al. Leukemia. 2006;20 :1467–1473; Rajkumar SV, et al. Blood. 2011;4691-4695), during or after the study treatment at the time of data cutoff.","definition_or_measurement_approach":"Response rate assessed according to IMWG criteria during or after study treatment at data cutoff."}
  • {"endpoint_text":"- Overall response rate, defined as the proportion of subjects who achieve CR or PR according to the IMWG criteria, following salvage therapy.","definition_or_measurement_approach":"Proportion of subjects achieving CR or PR per IMWG criteria following salvage therapy."}
  • {"endpoint_text":"- PFS which is defined as the duration from the date of randomization to either progressive disease, according to the IMWG criteria or death, at 4 years after randomization.","definition_or_measurement_approach":"Progression-free survival defined as time from randomization to IMWG-defined progression or death, assessed at 4 years after randomization."}
  • {"endpoint_text":"- Incidence of adverse events within the 4 years after randomization","definition_or_measurement_approach":"Incidence of adverse events captured within 4 years after randomization."}
  • {"endpoint_text":"- QoL will be evaluated after randomization every 12 weeks until disease progression and then at last follow-up based on the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) and the EQ-5D 5L (EuroQol - five dimension - five levels).","definition_or_measurement_approach":"Quality of life measured every 12 weeks using EORTC QLQ-C30 and EQ-5D-5L until progression and at last follow-up."}
  • {"endpoint_text":"- The Incremental cost-effectiveness ratios (ICERs) expressed in cost per quality adjusted life year (QALY) gained, in cost per Life Year Gained, and in cost per progression free year gained.","definition_or_measurement_approach":"Health economic outcomes: ICERs expressed as cost per QALY, cost per life year gained, and cost per progression-free year gained."}
  • {"endpoint_text":"- The budget impact analysis based upon target and prevalent populations’ estimations","definition_or_measurement_approach":"Budget impact analysis based on target and prevalent population estimates."}

Recruitment

Planned Sample Size
477
Recruitment Window Months
96
Consent Approach
Signed informed consent required from participants. Enrolment limited to adults (≥ 18 years). A subject information and informed consent form document is listed (L1_SIS and ICF_Patient). No assent process or specific languages for consent forms are described in the provided data.

Geography

Total Number Of Sites
51
Total Number Of Participants
477

France

Earliest CTIS Part Ii Submission Date
30-10-2024
Latest Decision Or Authorization Date
18-07-2025
Processing Time Days
261
Number Of Sites
51
Number Of Participants
477

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Hematology
Principal Investigator Name
Régis COSTELLO
Principal Investigator Email
Regis.COSTELLO@ap-hm.fr
Contact Person Name
Régis COSTELLO
Contact Person Email
Regis.COSTELLO@ap-hm.fr
Site Name
Hospices Civils De Lyon
Department Name
Hematology
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
Hematology
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
Assistance Publique Hopitaux De Paris
Department Name
Hematology
Principal Investigator Name
Mohamad MOTHY
Principal Investigator Email
mohamad.mohty@inserm.fr
Contact Person Name
Mohamad MOTHY
Contact Person Email
mohamad.mohty@inserm.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Hematology
Principal Investigator Name
Komivi AGBETSIVI
Principal Investigator Email
komivi.agbetsivi@ght85.fr
Contact Person Name
Komivi AGBETSIVI
Contact Person Email
komivi.agbetsivi@ght85.fr
Site Name
Centre Hospitalier De Versailles
Department Name
Hematology
Principal Investigator Name
Sophie RIGAUDEAU
Principal Investigator Email
srigaudeau@ch-versailles.fr
Contact Person Name
Sophie RIGAUDEAU
Contact Person Email
srigaudeau@ch-versailles.fr
Site Name
Oncopole Claudius Regaud
Department Name
Hematology
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 Caen Normandie
Department Name
Hematology
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 Regional Universitaire De Tours
Department Name
Hematology
Principal Investigator Name
Thomas CHALOPIN
Principal Investigator Email
t.chalopin@chu-tours.fr
Contact Person Name
Thomas CHALOPIN
Contact Person Email
t.chalopin@chu-tours.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Hematology
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
Centre Hospitalier Universitaire De Poitiers
Department Name
Hematology
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
CHRU De Nancy
Department Name
Hematology
Principal Investigator Name
Pierre FEUGIER
Principal Investigator Email
p.feugier@chru-nancy.fr
Contact Person Name
Pierre FEUGIER
Contact Person Email
p.feugier@chru-nancy.fr
Site Name
Centre Hospitalier Blois Simone Veil
Department Name
Hematology
Principal Investigator Name
Abderrazak EL YAMANI
Principal Investigator Email
elyamaa@ch-blois.fr
Contact Person Name
Abderrazak EL YAMANI
Contact Person Email
elyamaa@ch-blois.fr
Site Name
Centre Hospitalier D Avignon
Department Name
Onco-hematology
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
Institut Bergonie
Department Name
Hematology
Principal Investigator Name
Anna SCHMITT
Principal Investigator Email
a.schmitt@bordeaux.unicancer.fr
Contact Person Name
Anna SCHMITT
Site Name
Centre Hospitalier Saint Nazaire
Department Name
Hematology
Principal Investigator Name
Marion LOIRAT
Principal Investigator Email
m.loirat@ch-saintnazaire.fr
Contact Person Name
Marion LOIRAT
Contact Person Email
m.loirat@ch-saintnazaire.fr
Site Name
CH de Martigues
Department Name
Internal medicine
Principal Investigator Name
Rolande COHEN-VALENSI
Principal Investigator Email
rolande.cohenvalensi@ch-martigues.fr
Contact Person Name
Rolande COHEN-VALENSI
Site Name
Centre Hospitalier De Perigueux
Department Name
Onco-hematology
Principal Investigator Name
Claire CLAMETTES
Principal Investigator Email
claire.clamettes@ch-perigueux.fr
Contact Person Name
Claire CLAMETTES
Site Name
Centre Hospitalier William Morey
Department Name
Onco-hematology
Principal Investigator Name
Laurent VOILLAT
Principal Investigator Email
laurent.voillat@ch-chalon71.fr
Contact Person Name
Laurent VOILLAT
Contact Person Email
laurent.voillat@ch-chalon71.fr
Site Name
Centre Hospitalier Intercommunal De Cornouaille
Department Name
Internal medicine, blood diseases
Principal Investigator Name
Roan LA CALLOCH
Principal Investigator Email
r.lecalloch@ch-cornouaille.fr
Contact Person Name
Roan LA CALLOCH
Contact Person Email
r.lecalloch@ch-cornouaille.fr
Site Name
Centre Hospitalier De Bourg-En-Bresse
Department Name
Onco-hematology
Principal Investigator Name
Hubert ORFEUVRE
Principal Investigator Email
horfeuvre@ch-bourg01.fr
Contact Person Name
Hubert ORFEUVRE
Contact Person Email
horfeuvre@ch-bourg01.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Hematology
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 D'Abbeville
Department Name
Internal medicine
Principal Investigator Name
Isabelle LEDUC
Principal Investigator Email
leduc.isabelle@ch-abbeville.fr
Contact Person Name
Isabelle LEDUC
Contact Person Email
leduc.isabelle@ch-abbeville.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Hematology
Principal Investigator Name
Jean-Noel BASTIE
Principal Investigator Email
jean-noel.bastie@chu-dijon.fr
Contact Person Name
Jean-Noel BASTIE
Contact Person Email
jean-noel.bastie@chu-dijon.fr
Site Name
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
Department Name
Onco-hematology
Principal Investigator Name
Abdelaziz CHAIB
Principal Investigator Email
achaib@ch-aix.fr
Contact Person Name
Abdelaziz CHAIB
Contact Person Email
achaib@ch-aix.fr
Site Name
Institut Curie
Department Name
Oncology
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
Groupe Hospitalier Bretagne Sud
Department Name
Hematology
Principal Investigator Name
Adrien TRIBOUET
Principal Investigator Email
a.trebouet@ghbs.bzh
Contact Person Name
Adrien TRIBOUET
Contact Person Email
a.trebouet@ghbs.bzh
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hematology
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 Et Universitaire De Limoges
Department Name
Hematology
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
Clinique Victor Hugo
Department Name
Hematology
Principal Investigator Name
Marielle GOFF
Principal Investigator Email
essaislegoff@ilcgroupe.fre.voog
Contact Person Name
Marielle GOFF
Site Name
Centre Hospital Region Metz Thionville
Department Name
Hematology
Principal Investigator Name
Véronique DORVAUX
Principal Investigator Email
v.dorvaux@chr-metz-thionville.fr
Contact Person Name
Véronique DORVAUX
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Hematology
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
Centre Henri Becquerel
Department Name
Hematology
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
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hematology
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
Assistance Publique Hopitaux De Paris
Department Name
Hematology
Principal Investigator Name
Bertrand ARNULF
Principal Investigator Email
bertrand.arnulf@aphp.fr
Contact Person Name
Bertrand ARNULF
Contact Person Email
bertrand.arnulf@aphp.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Hematology
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
Centre Hospitalier Universitaire De Nantes
Department Name
Hematology
Principal Investigator Name
Philippe MOREAU
Principal Investigator Email
philippe.moreau@chu-nantes.fr
Contact Person Name
Philippe MOREAU
Contact Person Email
philippe.moreau@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hematology
Principal Investigator Name
Laure VINCENT
Principal Investigator Email
vincent@chu-montpellier.fr
Contact Person Name
Laure VINCENT
Contact Person Email
vincent@chu-montpellier.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hematology
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
L'Hopital Prive Du Confluent
Department Name
Hematology
Principal Investigator Name
Jacques DELAUNAY
Principal Investigator Email
jacques.delaunay@groupeconfluent.fr
Contact Person Name
Jacques DELAUNAY
Site Name
Groupement Des Hopitaux De L'Institut Catholique De Lille
Department Name
Hematology
Principal Investigator Name
Emmanuelle BOURGEOIS-PETIT
Principal Investigator Email
bourgeois.emmanuelle@ghicl.net
Contact Person Name
Emmanuelle BOURGEOIS-PETIT
Contact Person Email
bourgeois.emmanuelle@ghicl.net
Site Name
Centre Hospitalier Annecy Genevois
Department Name
Hematology
Principal Investigator Name
Frédérique ORCINI-PIOCELLE
Principal Investigator Email
forsinipiocelle@ch-annecygenevois.fr
Contact Person Name
Frédérique ORCINI-PIOCELLE
Site Name
Hopital Prive Sevigne
Department Name
Hematology
Principal Investigator Name
Benoît BAREAU
Principal Investigator Email
benoit.bareau@gmail.com
Contact Person Name
Benoît BAREAU
Contact Person Email
benoit.bareau@gmail.com
Site Name
Centre Hospitalier Intercommunal Compiegne Noyon
Department Name
Onco-hematology
Principal Investigator Name
Kossi Claude AGBETIAFA
Principal Investigator Email
k.agbetiafa@ch-compiegnenoyon.fr
Contact Person Name
Kossi Claude AGBETIAFA
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Hematology
Principal Investigator Name
Emilie CHALAYER
Principal Investigator Email
emilie.chalayer@chu-st-etienne.fr
Contact Person Name
Emilie CHALAYER
Site Name
Centre Hospitalier De Saint-Quentin
Department Name
Onco-hematology
Principal Investigator Name
Reda GARIDI
Principal Investigator Email
R.GARIDI@ch-stquentin.fr
Contact Person Name
Reda GARIDI
Contact Person Email
R.GARIDI@ch-stquentin.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Hematology
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 Metropole Savoie
Department Name
Hematology
Principal Investigator Name
Arthur DONY
Principal Investigator Email
arthur.dony@ch-metropole-savoie.fr
Contact Person Name
Arthur DONY
Site Name
Hopital D'Instruction Des Armees Percy
Department Name
Hematology
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 Universitaire De Lille
Department Name
Hematology
Principal Investigator Name
Salomon MANIER
Principal Investigator Email
salomon.manier@chru-lille.fr
Contact Person Name
Salomon MANIER
Contact Person Email
salomon.manier@chru-lille.fr
Site Name
Centre Hospitalier Bretagne Atlantique
Department Name
Internal medicine
Principal Investigator Name
Pascal GODMER
Principal Investigator Email
pascal.godmer@ch-bretagne-atlantique.fr
Contact Person Name
Pascal GODMER

Sponsor

Primary sponsor

Full Name
Assistance Publique Hopitaux De Paris
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
DEXAMETHASONE
Active Substance
BETAMETHASONE SODIUM PHOSPHATE
Modality
Small molecule
Routes Of Administration
ORAL AND IV
Route
ORAL AND IV
Maximum Dose
40 mg (max daily dose as listed)
Investigational Product Name
DARATUMUMAB
Active Substance
DARATUMUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
16 mg/kg (max daily dose as listed, unit mg/kg)
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 (marketing authorisation number listed)
Starting Dose
1800 mg (product listed as DARZALEX 1800 mg solution for injection)
Dose Levels
1800 mg
Maximum Dose
1800 mg (max daily dose as listed)
Investigational Product Name
LENALIDOMIDE
Active Substance
Lenalidomide
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Maximum Dose
25 mg (max daily dose as listed)
Combination Treatment
Yes

Related trials

Other published trials that may interest you.