Isatuximab in Combination with REGN2810 in 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-HU
• Lead Sponsor: Sanofi-aventis recherche & developpement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-07
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

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)
OR
- Patients whose disease is double refractory to an IMID and a PI (disease progression has occurred while on or within 60 days from end of the treatment).

- Patient must have achieved MR or better with any anti-myeloma therapy (ie, primary refractory disease is not eligible).

- Patients must have a disease that is refractory to the most recent prior line therapy (disease progression has occurred while on treatment or within 60 days from end of the treatment).
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 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

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.
- 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