Status:
RECRUITING
Study Comparing Therapy for Advanced Relapsed/Refractory Multiple Myeloma With and Without Dexamethasone
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Multiple Myeloma
Relapse Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 dexamethaso...
Detailed Description
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 dexamethaso...
Eligibility Criteria
Inclusion
- Adult patients (≥18 years old)
- Documented MM in relapse according to standard criteria.
- 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:
- ICARIA schema: isatuximab, pomalidomide and dexamethasone.
- IKEMA schema: isatuximab, carfilzomib and dexamethasone
- Subject must have achieved a response (PR or better) to the prior regimen.
- ECOG Performance Status score of 0, 1, or 2.
- For subjects experiencing toxicities resulting from previous therapy (including peripheral neuropathy), the toxicities must have been resolved or stabilized.
- Signed informed consent
Exclusion
- Contraindications to investigational medicinal products or auxiliary medicinal product
- Evidence of refractoriness or intolerance to anti-CD38 monoclonal antibodies.
- Previous treatment according to the ICARIA schema with pomalidomide or IKEMA schema with carfilzomib
- Allogenic hematopoietic cell transplant (HCT, regardless of timing).
- 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.
- 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).
- Known MM meningeal Involvement.
- 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.
- 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.
- Uncontrolled chronic obstructive pulmonary disease (COPD)
- Clinically significant cardiac disease.
- Seropositive for hepatitis B with positive PCR
- Seropositive for human immunodeficiency virus (HIV) or hepatitis C
- Lactation
- Participation to another interventional clinical trial
- Inability to give written informed consent
Key Trial Info
Start Date :
December 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT06561854
Start Date
December 12 2024
End Date
December 1 2028
Last Update
December 18 2024
Active Locations (1)
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1
Service d'hématologie clinique et thérapie cellulaire, Saint-Antoine Hospital
Paris, France, 75012