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: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-20
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 534

Inclusion Criteria

- Participants with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor, and with 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 214
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 320

Exclusion Criteria

- Participants are excluded from the study if any of the following criteria apply
Medical conditions:
- Participants less than 18 years old, participants with Eastern Cooperative Oncology Group performance status more than 2
-Primary refractory multiple myeloma participants
-Participants refractory to anti-CD38 with a wash-out period inferior to 9 months or intolerant to anti-CD38 mAb agents
-Prior therapy with pomalidomide
- Participants with inadequate biological tests.
-Significant cardiac dysfunction
- Participants diagnosed or treated for another cancer 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
-Concomittant plasma cell leukemia
-Active primary amyloid-light (AL) amyloidosis
-Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
-Hepatitis A, B, or C active infection
-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