Free regimen of Dexamethasone as initial therapy for advanced relapsed/refractory multiple myeloma: an open-label randomized, non-inferiority, controlled trial

Phase 1

• Conditions: Multiple MyelomaMultiple myeloma (MM) is a B cell malignancy and is one of the most frequent primary neoplasms of the bone marrow; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

• Registration Number: CTIS2024-510981-18-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

•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 (see 2.6 for details on EMEA authorization): (1) ICARIA schema: isatuximab, pomalidomide and dexamethasone. (2) 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 Criteria

•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 orIKEMA schema with carfilzomib •Allogenic hematopoietic cell transplant (HCT, regardless of timing). •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. •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. •Creatinine clearance =30 mL/min •Pregnancy or absence of effective contraceptive method for women of childbearing potential •Lactation •Participation to another interventional clinical trial •Inability to give written informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified