Informations générales (source: ClinicalTrials.gov)
Free Regimen of Dexamethasone as Initial Therapy for Advanced Relapsed/Refractory Multiple Myeloma: an Open-label Randomized, Non-inferiority, Controlled Trial
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
décembre 2024
décembre 2028
04 septembre 2025
Patients with relapsed/refractory symptomatic multiple myeloma who meet all inclusion
criteria, will be randomized 1:1 to receive either standard of care chemotherapy (IKEMA
or ICARIA) and dexamethasone until disease progression ("dexamethasone arm", arm A) or
standard of care chemotherapy (IKEMA or ICARIA) and dexamethasone with dexamethasone
discontinuation from the 3rd cycle of treatment (after 8 weeks) ("dexamethasone-free
arm", arm B).
In most centers, IKEMA and ICARIA schema can be adapted according to the standard of care
in each center Choice between the ICARIA and IKEMA schema is at the discretion of the
investigator, in compliance with each drug's SmPC, but must be performed before
randomisation for the purpose of stratification.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH VICTOR DUPOUY ARGENTEUIL | MOHTY Mohamad | 13/12/2025 07:40:36 | Contacter | ||
| CH DE VERSAILLES SITE ANDRE MIGNOT | MOHTY Mohamad | 13/12/2025 07:40:35 | Contacter | ||
| HIA PERCY | MOHTY Mohamad | 13/12/2025 07:40:36 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:40:36 | Contacter | |||
| AP-HP - Hôpital Avicenne | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Necker-Enfants Malades | |||||
| AP-HP - Hôpital Saint Antoine | |||||
| AP-HP - Hôpital Saint Louis | |||||
Critères
Tous
Inclusion Criteria:
1. Adult patients (≥18 years old)
2. Documented MM in relapse according to standard criteria.
3. 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)
- Eligible for one of the following antibody-based approved combinations:
1. ICARIA schema: isatuximab, pomalidomide and dexamethasone.
2. IKEMA schema: isatuximab, carfilzomib and dexamethasone
4. Subject must have achieved a response (PR or better) to the prior regimen.
5. ECOG Performance Status score of 0, 1, or 2.
6. For subjects experiencing toxicities resulting from previous therapy (including
peripheral neuropathy), the toxicities must have been resolved or stabilized.
7. Signed informed consent
1. Adult patients (≥18 years old)
2. Documented MM in relapse according to standard criteria.
3. 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)
- Eligible for one of the following antibody-based approved combinations:
1. ICARIA schema: isatuximab, pomalidomide and dexamethasone.
2. IKEMA schema: isatuximab, carfilzomib and dexamethasone
4. Subject must have achieved a response (PR or better) to the prior regimen.
5. ECOG Performance Status score of 0, 1, or 2.
6. For subjects experiencing toxicities resulting from previous therapy (including
peripheral neuropathy), the toxicities must have been resolved or stabilized.
7. Signed informed consent
1. Contraindications to investigational medicinal products or auxiliary medicinal
product
2. Evidence of refractoriness or intolerance to anti-CD38 monoclonal antibodies.
3. Previous treatment according to the ICARIA schema with pomalidomide or IKEMA schema
with carfilzomib
4. Allogenic hematopoietic cell transplant (HCT, regardless of timing).
5. Planned to undergo an hematopoietic cell transplant prior to progression of disease
ie, these patients should not be enrolled in order to reduce disease burden prior to
transplant.
6. 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).
7. Known MM meningeal Involvement.
8. 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.
9. 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.
10. Uncontrolled chronic obstructive pulmonary disease (COPD)
11. Clinically significant cardiac disease.
12. Seropositive for hepatitis B with positive PCR
13. Seropositive for human immunodeficiency virus (HIV) or hepatitis C
14. Lactation
15. Participation to another interventional clinical trial
16. Inability to give written informed consent