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

Recruiting now · Phase 3

Conditions studied: Multiple Myeloma, Relapse Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT06561854

Run by

Assistance Publique - Hôpitaux de Paris

People needed

318

Starts

2024-12-12

Expected to finish

2028-12-01

Last updated by the study team

2024-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Service d'hématologie clinique et thérapie cellulaire, Saint-Antoine Hospital — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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