NCT06561854 Study Comparing Therapy for Advanced Relapsed/Refractory Multiple Myeloma With and Without Dexamethasone

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 318 participants in total. It began in 2024-12-12 with a primary completion date of 2028-12.

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 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.

Eligibility Criteria

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 Exclusion Criteria: 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

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