Isatuximab in Combination with Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients

Phase 1

• Conditions: Cancer; MedDRA version: 20.0Level: PTClassification code 10035226Term: Plasma cell myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001431-39-GR
• Lead Sponsor: Sanofi-aventis recherche & developpement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-29
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

- Patients must have a known diagnosis of multiple myeloma with evidence of measurable disease, as defined below:
-> Serum M-protein =1 g/dL (=0.5 g/dL in case of IgA disease),
AND/OR
-> Urine M-protein =200 mg/24 hours,
OR
-> In the absence of measurable m-protein, serum immunoglobulin free light chain =10 mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio (<0.26 or >1.65).

- Patients must have received prior treatment with an IMiD (for =2 cycles or =2 months of treatment) and a proteasome inhibitor (for =2 cycles or =2 months of treatment).

- Patients must have received at least 3 prior lines of therapy (Note: Induction therapy and stem cell transplant ± maintenance will be considered as one line)

- Patient must have achieved MR or better with any anti-myeloma therapy (ie, primary refractory disease is not eligible).
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 73

Exclusion Criteria

- Prior exposure to isatuximab or participated clinical studies with isatuximab.
- Prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1 pathway.
- Evidence of other immune related disease /conditions.
- History of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation.
- Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
- Has allogenic haemopoietic stem cell (HSC) transplant.
- Prior treatment with idelalisib (a PI3K inhibitor).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2.
- Poor bone marrow reserve.
- Poor organ function.

Study & Design

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