Phase 3 study evaluating subcutaneous versus intravenous administration of isatuximab in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM)

Phase 1

• Conditions: Multiple Myeloma; MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-002485-41-DE
• Lead Sponsor: Sanofi-aventis recherche & developpement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 614

Inclusion Criteria

- Participants with multiple myeloma who have received at least one prior line of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination
- measurable serum M-protein (= 0.5 g/dL) and/or urine M-protein (= 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay =10 mg/dL and abnormal serum FLC ratio (<0.26 or >1.65))
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 246
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 368

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
- Primary refractory multiple myeloma participants
-Participants with prior anti-CD38 treatment: (a) administered a less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received
- Prior therapy with pomalidomide
- Participants with inadequate biological tests.
- Significant cardiac dysfunction
- Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
- Concomitant plasma cell leukemia
- Active primary amyloid-light chain amyloidosis
- Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
- Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
- Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control
The above information is not intended to contain all considerations
relevant to a participant's potential participation in a clinical trial

Study & Design

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