Clinical trial • Phase III • Haematology
DEXAMETHASONE for Multiple myeloma
Phase III trial of DEXAMETHASONE for Multiple myeloma.
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Multiple myeloma
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 01-05-2024
- First CTIS Authorization Date
- 23-07-2024
Trial design
Randomised, open-label, standard of care chemotherapy (investigator pre-selected icaria schema: isatuximab + pomalidomide + dexamethasone or ikema schema: isatuximab + carfilzomib + dexamethasone) with continuous dexamethasone until progression ("dexamethasone arm", arm a) versus the same soc chemotherapy with dexamethasone discontinued from the 3rd cycle (after 8 weeks) ("dexamethasone-free arm", arm b). doses and schedules not specified in the provided text.-controlled Phase III trial across 46 sites in France.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Standard of care chemotherapy (investigator pre-selected ICARIA schema: isatuximab + pomalidomide + dexamethasone OR IKEMA schema: isatuximab + carfilzomib + dexamethasone) with continuous dexamethasone until progression ("dexamethasone arm", arm A) versus the same SOC chemotherapy with dexamethasone discontinued from the 3rd cycle (after 8 weeks) ("dexamethasone-free arm", arm B). Doses and schedules not specified in the provided text.
- Target Sample Size
- 334
- Trial Duration For Participant
- 730
Stratification factors
- Choice of treatment schema (ICARIA vs IKEMA) performed before randomisation for stratification
Eligibility
Recruits 334 No vulnerable populations selected. Trial enrols adult patients (≥18 years). Participants must provide signed informed consent (see ICF documents). Inability to give written informed consent is an exclusion criterion. No assent/child consent procedures are described..
- Pregnancy Exclusion
- Pregnancy or absence of effective contraceptive method for women of childbearing potential
- Vulnerable Population
- No vulnerable populations selected. Trial enrols adult patients (≥18 years). Participants must provide signed informed consent (see ICF documents). Inability to give written informed consent is an exclusion criterion. No assent/child consent procedures are described.
Inclusion criteria
- {"criterion_text":"- Adult patients (≥18 years old)\n- Documented MM in relapse according to standard criteria.\n- All patients must have received between 1 to 3 prior therapies for MM (a prior therapy is defined as 2 or more cycles of therapy given as a MM treatment plan\n- Eligible for one of the following antibody-based approved combinations (see 2.6 for details on EMEA authorization): (1) ICARIA schema: isatuximab, pomalidomide and dexamethasone. (2) IKEMA schema: isatuximab, carfilzomib and dexamethasone\n- Subject must have achieved a response (PR or better) to the prior regimen.\n- ECOG Performance Status score of 0, 1, or 2.\n- For subjects experiencing toxicities resulting from previous therapy (including peripheral neuropathy), the toxicities must have been resolved or stabilized.\n- Signed informed consent"}
Exclusion criteria
- {"criterion_text":"- Contraindications to investigational medicinal products or auxiliary medicinal product\n- Evidence of refractoriness or intolerance to anti-CD38 monoclonal antibodies or if the patient received an anti-CD38 within the last 6 months.\n- Previous treatment according to the ICARIA schema with pomalidomide orIKEMA schema with carfilzomib\n- Allogenic hematopoietic cell transplant (HCT, regardless of timing).\n- Planned to undergo an HCT prior to progression of disease ie, these patients should not be enrolled in order to reduce disease burden prior to transplant.\n- 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).\n- Known MM meningeal Involvement.\n- 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.\n- Any concurrent medical condition or disease (e.g., 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 by participating in this study.\n- Uncontrolled chronic obstructive pulmonary disease (COPD)\n- Clinically significant cardiac disease.\n- Seropositive for hepatitis B with positive PCR\n- Seropositive for human immunodeficiency virus (HIV) or hepatitis C.\n- Creatinine clearance ≤30 mL/min\n- Pregnancy or absence of effective contraceptive method for women of childbearing potential\n- Lactation\n- Participation to another interventional clinical trial except with the agreement of the coordinating investigator.\n- Inability to give written informed consent"}
Endpoints
Primary endpoints
- {"endpoint_text":"- the ORR after six cycles of salvage therapy, defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) according to the IMWG criteria, following salvage therapy.","definition_or_measurement_approach":"Overall response rate (ORR) after six cycles of salvage therapy measured as the proportion of subjects achieving CR or PR according to the International Myeloma Working Group (IMWG) criteria."}
Secondary endpoints
- {"endpoint_text":"- Best ORR, defined as the proportion of subjects who achieve CR or PR according to the IMWG criteria, at any time point following salvage therapy.\n- Time to progression (TTP)\n- Progression-free survival (PFS) defined as the duration from the date of randomization to either progressive disease, according to the IMWG criteria, or death, at 2 years after randomization.\n- OS defined as the duration from the date of randomization to death, at 2 years after randomization.\n- Incidence of adverse events (AE) within the 2 years after randomization.\n- Quality of Life (QoL) within the 2 years after randomization.","definition_or_measurement_approach":"Best ORR: proportion achieving CR or PR by IMWG criteria at any time post-salvage; TTP: time from randomization to progression; PFS: time from randomization to progression per IMWG or death (assessed at 2 years); OS: time from randomization to death (assessed at 2 years); Incidence of AEs: collected within 2 years after randomization; QoL: assessed within 2 years after randomization (specific instruments not described here)."}
Recruitment
- Planned Sample Size
- 334
- Recruitment Window Months
- 46
- Consent Approach
- Adult participants must provide signed written informed consent. Subject Information Sheet and Informed Consent Form documents (L1_SIS and L1_SIS-ICF adult/majeur) are listed for publication. Inability to give written informed consent is an exclusion criterion. No specific languages or assent procedures are described in the available data.
Geography
- Total Number Of Sites
- 46
- Total Number Of Participants
- 334
France
- Earliest CTIS Part Ii Submission Date
- 12-06-2024
- Latest Decision Or Authorization Date
- 17-11-2025
- Processing Time Days
- 523
- Number Of Sites
- 46
- Number Of Participants
- 334
Sites
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- HEMATOLOGIE CLINIQUE
- Principal Investigator Name
- VINCENT Laure
- Principal Investigator Email
- l-vincent@chu-montpellier.fr
- Contact Person Name
- VINCENT Laure
- Contact Person Email
- l-vincent@chu-montpellier.fr
- Site Name
- Chorale Du Centre Hospitalier De Lens
- Department Name
- Service 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 Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
- Department Name
- ONCO HEMATOLOGIE MEDECINE INTERNE
- Principal Investigator Name
- CHAIB Abdelaziz
- Principal Investigator Email
- achaib@ch-aix.fr
- Contact Person Name
- CHAIB Abdelaziz
- Contact Person Email
- achaib@ch-aix.fr
- Site Name
- Groupe Hospitalier Du Havre
- Department Name
- Service Hématologie
- 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 Universitaire Grenoble Alpes
- Department Name
- HEMATOLOGIE
- Principal Investigator Name
- MARIETTE Clara
- Principal Investigator Email
- CMariette@chu-grenoble.fr
- Contact Person Name
- MARIETTE Clara
- Contact Person Email
- CMariette@chu-grenoble.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service des maladies du sang
- Principal Investigator Name
- MANIER Salomon
- Principal Investigator Email
- Salomon.manier@chu-lille.fr
- Contact Person Name
- MANIER Salomon
- Contact Person Email
- Salomon.manier@chu-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service Hématologie clinique
- Principal Investigator Name
- TOUZEAU Cyrille
- Principal Investigator Email
- cyrille.touzeau@chu-nantes.fr
- Contact Person Name
- TOUZEAU Cyrille
- Contact Person Email
- cyrille.touzeau@chu-nantes.fr
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- HEMATOLOGIE
- Principal Investigator Name
- AGBETSIVI Komivi 02 51 44 61 73
- Principal Investigator Email
- komivi.agbetsivi@ght85.fr
- Contact Person Name
- AGBETSIVI Komivi 02 51 44 61 73
- Contact Person Email
- komivi.agbetsivi@ght85.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Creteil Cedex)
- Department Name
- HEMATOLOGIE
- Principal Investigator Name
- BELHADJ KARIM
- Principal Investigator Email
- karim.belhadj@hmn.aphp.fr
- Contact Person Name
- BELHADJ KARIM
- Contact Person Email
- karim.belhadj@hmn.aphp.fr
- Site Name
- Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
- Department Name
- hematologie
- Principal Investigator Name
- ROUL Christophe
- Principal Investigator Email
- christophe.roul@ght-atlantique17.fr
- Contact Person Name
- ROUL Christophe
- Contact Person Email
- christophe.roul@ght-atlantique17.fr
- Site Name
- Institut De Cancerologie De Bourgogne
- Department Name
- Service Hématologie
- Principal Investigator Name
- Lafon Ingrid
- Principal Investigator Email
- ilafon@icb-cancer.fr
- Contact Person Name
- Lafon Ingrid
- Contact Person Email
- ilafon@icb-cancer.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- Service Hématologie clinique
- Principal Investigator Name
- GODET Sophie
- Principal Investigator Email
- sophie.godet@chu-reims.fr
- Contact Person Name
- GODET Sophie
- Contact Person Email
- sophie.godet@chu-reims.fr
- Site Name
- Centre Hospitalier William Morey
- Department Name
- HEMATOLOGIE ONCOLOGIE
- Principal Investigator Name
- KENNEL Céline
- Principal Investigator Email
- celine.kennel@ch-chalon71.fr
- Contact Person Name
- KENNEL Céline
- Contact Person Email
- celine.kennel@ch-chalon71.fr
- Site Name
- Centre Hospitalier De Versailles
- Department Name
- Service Hématologie
- Principal Investigator Name
- RIGAUDEAU Sophie
- Principal Investigator Email
- srigaudeau@ght78sud.fr
- Contact Person Name
- RIGAUDEAU Sophie
- Contact Person Email
- srigaudeau@ght78sud.fr
- Site Name
- Institut Bergonie
- Department Name
- Service Hématologie
- Principal Investigator Name
- SCHMITT Anna
- Principal Investigator Email
- a.schmitt@bordeaux.unicancer.fr
- Contact Person Name
- SCHMITT Anna
- Contact Person Email
- a.schmitt@bordeaux.unicancer.fr
- Site Name
- Centre Hospitalier Metropole Savoie
- Department Name
- Service Hématologie
- Principal Investigator Name
- DONY Arthur
- Principal Investigator Email
- arthur.dony@ch-metropole-savoie.fr
- Contact Person Name
- DONY Arthur
- Contact Person Email
- arthur.dony@ch-metropole-savoie.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Paris Cedex 15)
- Department Name
- Service Hématologie adultes
- Principal Investigator Name
- Frenzel Laurent
- Principal Investigator Email
- laurent.frenzel@aphp.fr
- Contact Person Name
- Frenzel Laurent
- Contact Person Email
- laurent.frenzel@aphp.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Service de thérapie cellulaire et d’hématologie clinique
- Principal Investigator Name
- Carolyne CROIZIER
- Principal Investigator Email
- ccroizier@chu-clermontferrand.fr
- Contact Person Name
- Carolyne CROIZIER
- Contact Person Email
- ccroizier@chu-clermontferrand.fr
- Site Name
- Groupement Des Hopitaux De L'Institut Catholique De Lille
- Department Name
- HEMATOLOGIE
- Principal Investigator Name
- BOURGEOIS-PETIT Emmanuelle
- Principal Investigator Email
- bourgeois.emmanuelle@ghicl.net
- Contact Person Name
- BOURGEOIS-PETIT Emmanuelle
- Contact Person Email
- bourgeois.emmanuelle@ghicl.net
- Site Name
- Assistance Publique Hopitaux De Paris (Bobigny Cedex)
- Department Name
- Service Hématologie
- Principal Investigator Name
- BRAUN Thorsten
- Principal Investigator Email
- Thorsten.braun@aphp.fr
- Contact Person Name
- BRAUN Thorsten
- Contact Person Email
- Thorsten.braun@aphp.fr
- Site Name
- Centre Hospitalier De Perigueux
- Department Name
- hematologie
- Principal Investigator Name
- CLAMETTES Claire
- Principal Investigator Email
- claire.clamettes@ch-perigueux.fr
- Contact Person Name
- CLAMETTES Claire
- Contact Person Email
- claire.clamettes@ch-perigueux.fr
- Site Name
- Direction Centrale Du Service De Sante Des Armees
- Department Name
- HEMATOLOGIE
- Principal Investigator Name
- MAILLOT Jean
- Principal Investigator Email
- jean.maillot@intradef.gouv.fr
- Contact Person Name
- MAILLOT Jean
- Contact Person Email
- jean.maillot@intradef.gouv.fr
- Site Name
- Groupe Hospitalier Bretagne Sud
- Department Name
- Service Médecine Hématologie – VIH
- Principal Investigator Name
- Claire BREAL
- Principal Investigator Email
- c.breal@ghbs.bzh
- Contact Person Name
- Claire BREAL
- Contact Person Email
- c.breal@ghbs.bzh
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- HEMATOLOGIE
- Principal Investigator Name
- SAPET Manon
- Principal Investigator Email
- manon.sapet@chu-st-etienne.fr
- Contact Person Name
- SAPET Manon
- Contact Person Email
- manon.sapet@chu-st-etienne.fr
- Site Name
- L'Hopital Prive Du Confluent
- Department Name
- HEMATOLOGIE
- Principal Investigator Name
- DELAUNAY Jacques
- Principal Investigator Email
- jacques.delaunay@groupeconfluent.fr
- Contact Person Name
- DELAUNAY Jacques
- Contact Person Email
- jacques.delaunay@groupeconfluent.fr
- Site Name
- Centre Hospitalier Annecy Genevois
- Department Name
- HEMATOLOGIE
- Principal Investigator Name
- ORSINI-PIOCELLE Dr Frédérique
- Principal Investigator Email
- forsinipiocelle@ch-annecygenevois.fr
- Contact Person Name
- ORSINI-PIOCELLE Dr Frédérique
- Contact Person Email
- forsinipiocelle@ch-annecygenevois.fr
- Site Name
- Hopital Saint Louis
- Department Name
- Immuno-Hématologie
- Principal Investigator Name
- HAREL Stéphanie
- Principal Investigator Email
- stephanie.harel@aphp.fr
- Contact Person Name
- HAREL Stéphanie
- Contact Person Email
- stephanie.harel@aphp.fr
- Site Name
- Centre Hospitalier D Avignon
- Department Name
- ONCO HEMATOLOGIE
- Principal Investigator Name
- CHEBREK Safia
- Principal Investigator Email
- chebrek.safia@ch-avignon.fr
- Contact Person Name
- CHEBREK Safia
- Contact Person Email
- chebrek.safia@ch-avignon.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Service Hématologie
- Principal Investigator Name
- MACRO Margaret
- Principal Investigator Email
- macro-m@chu-caen.fr
- Contact Person Name
- MACRO Margaret
- Contact Person Email
- macro-m@chu-caen.fr
- Site Name
- L’Hopital Alexandra Lepeve
- Department Name
- Service 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 Hospital Region Metz Thionville
- Department Name
- Hematologie
- Principal Investigator Name
- DORVAUX Véronique
- Principal Investigator Email
- v.dorvaux@chr-metz-thionville.fr
- Contact Person Name
- DORVAUX Véronique
- Contact Person Email
- v.dorvaux@chr-metz-thionville.fr
- Site Name
- Centre Hospitalier De Troyes
- Department Name
- Service Hématologie
- Principal Investigator Name
- Alberto Santagostino
- Principal Investigator Email
- alberto.santagostino@hcs-sante.fr
- Contact Person Name
- Alberto Santagostino
- Contact Person Email
- alberto.santagostino@hcs-sante.fr
- Site Name
- Les Hopitaux De Chartres
- Department Name
- ONCOLOGIE HEMATOLOGIE
- Principal Investigator Name
- DE LABARTHE Adrienne
- Principal Investigator Email
- adelabarthe@ch-chartres.fr
- Contact Person Name
- DE LABARTHE Adrienne
- Contact Person Email
- adelabarthe@ch-chartres.fr
- Site Name
- CH Argenteuil
- Department Name
- Service Hématologie
- Principal Investigator Name
- CHAOUI Driss
- Principal Investigator Email
- driss.chaoui@ch-argenteuil.fr
- Contact Person Name
- CHAOUI Driss
- Contact Person Email
- driss.chaoui@ch-argenteuil.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Service Hématologie et thérapie cellulaire
- Principal Investigator Name
- CHALOPIN Thomas
- Principal Investigator Email
- t.chalopin@chu-tours.fr
- Contact Person Name
- CHALOPIN Thomas
- Contact Person Email
- t.chalopin@chu-tours.fr
- Site Name
- Centre Henri Becquerel
- Department Name
- HEMATOLOGIE
- Principal Investigator Name
- LENAIN Pascal
- Principal Investigator Email
- pascal.lenain@chb.unicancer.fr
- Contact Person Name
- LENAIN Pascal
- Contact Person Email
- pascal.lenain@chb.unicancer.fr
- Site Name
- Clinique Du Parc
- Department Name
- Service Hématologie
- Principal Investigator Name
- Alexandre PAYSSOT
- Principal Investigator Email
- alexandre.payssot.hematoparc@outlook.fr
- Contact Person Name
- Alexandre PAYSSOT
- Contact Person Email
- alexandre.payssot.hematoparc@outlook.fr
- Site Name
- Centre Hospitalier Blois Simone Veil
- Department Name
- Service Oncologie-Hématologie
- Principal Investigator Name
- EL YAMANI Abderrazak
- Principal Investigator Email
- elyamaa@ch-blois.fr
- Contact Person Name
- EL YAMANI Abderrazak
- Contact Person Email
- elyamaa@ch-blois.fr
- Site Name
- Centre Hospitalier D'Abbeville
- Department Name
- Service Médecine Interne
- Principal Investigator Name
- LEDUC Isabelle
- Principal Investigator Email
- leduc.isabelle@ch-abbeville.fr
- Contact Person Name
- LEDUC Isabelle
- Contact Person Email
- leduc.isabelle@ch-abbeville.fr
- Site Name
- Centre Hospitalier Bretagne Atlantique
- Department Name
- HEMATOLOGIE
- Principal Investigator Name
- CHEREL Brieuc
- Principal Investigator Email
- Brieuc.cherel@ch-bretagne-atlantique.fr
- Contact Person Name
- CHEREL Brieuc
- Contact Person Email
- Brieuc.cherel@ch-bretagne-atlantique.fr
- Site Name
- Centre Hospitalier De Saint-Quentin
- Department Name
- HEMATOLOGIE
- Principal Investigator Name
- GARIDI Reda
- Principal Investigator Email
- R.GARIDI@ch-stquentin.fr
- Contact Person Name
- GARIDI Reda
- Contact Person Email
- R.GARIDI@ch-stquentin.fr
- Site Name
- Hopital Saint Antoine
- Department Name
- hematologie
- Principal Investigator Name
- MALARD Florent
- Principal Investigator Email
- florent.malard@aphp.fr
- Contact Person Name
- MALARD Florent
- Contact Person Email
- florent.malard@aphp.fr
- Site Name
- CHRU De Nancy
- Department Name
- Service Hématologie
- Principal Investigator Name
- JACQUET Caroline
- Principal Investigator Email
- c.jacquet@chru-nancy.fr
- Contact Person Name
- JACQUET Caroline
- Contact Person Email
- c.jacquet@chru-nancy.fr
- Site Name
- Hopital Prive Sevigne
- Department Name
- HEMATOLOGIE
- Principal Investigator Name
- BAREAU Benoît
- Principal Investigator Email
- benoit.bareau@gmail.com
- Contact Person Name
- BAREAU Benoît
- Contact Person Email
- benoit.bareau@gmail.com
- Site Name
- Centre Hospitalier De Niort
- Department Name
- HEMATOLOGIE
- Principal Investigator Name
- OLIVIER Gaelle
- Principal Investigator Email
- Gaelle.OLIVIER@ch-niort.fr
- Contact Person Name
- OLIVIER Gaelle
- Contact Person Email
- Gaelle.OLIVIER@ch-niort.fr
- Site Name
- Centre Hospitalier Intercommunal Compiegne Noyon
- Department Name
- Service Hématologie
- Principal Investigator Name
- AGBETIAFA Kossi Claude
- Principal Investigator Email
- k.agbetiafa@ch-compiegnenoyon.fr
- Contact Person Name
- AGBETIAFA Kossi Claude
- Contact Person Email
- k.agbetiafa@ch-compiegnenoyon.fr
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 (TABLET)
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 40 mg (max daily dose)
- Investigational Product Name
- DEXAMETHASONE (SOLUTION FOR INJECTION)
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- INTRAMUSCULAR AND INTRAVENOUS
- Route
- INTRAMUSCULAR AND INTRAVENOUS
- Maximum Dose
- 40 mg (max daily dose)
- Investigational Product Name
- DEXAMETHASONE (ORAL SOLUTION)
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 40 mg (max daily dose)
- Combination Treatment
- Yes
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