SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients

Status: Closed to Accrual

Description

Primary Objectives: Part A: To evaluate the safety and determine the recommended dose of SAR650984 in combination with pomalidomide (P) and dexamethasone (d), in patients with Relapsed / Refractory Multiple Myeloma (RRMM). Part B: To evaluate the feasibility of isatuximab administered from a fixed infusion volume in combination with Pd as assessed by occurrence of grade ≥3 infusion associated reactions (IAR). Secondary Objectives: - To evaluate the infusion duration (Part B). - To evaluate the safety profile of the combination with isatuximab administration from fixed volume (Part B). - To evaluate immunogenicity of SAR650984 in combination with Pd (Part A and B). - To evaluate the pharmacokinetics (PK) of SAR650984 and its effect on the PK of pomalidomide when administered in combination (Part A). - To describe the efficacy of the combination of SAR650984 with Pd in terms of overall response rate and clinical benefit rate based on International Myeloma Working Group (IMWG) defined response criteria and the duration of response (Part A and B). - To assess the relationship between clinical effects (adverse event [AE] and / or tumor response) and CD38 receptor density at baseline (Part A).

Eligibility Criteria

Inclusion Criteria

  • Patient has been previously diagnosed with multiple myeloma (MM) based on standard criteria and currently requires treatment because MM has relapsed following a response, according to International Myeloma Working Group (IMWG) criteria.
  • Patient had received at least two previous therapies including lenalidomide and proteasome inhibitor and have demonstrated disease progression on therapy or after completion of the last therapy.
  • Patients with measurable disease defined as at least one of the following:
  • Serum M protein ≥0.5 g/dL (≥5 g/L);
  • Urine M protein ≥200 mg/24 hours;
  • Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).

Exclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status >2.
  • Poor bone marrow reserve.
  • Poor organ function.
  • Known intolerance/hypersensitivity to IMiDs, dexamethasone, boron or mannitol, sucrose, histidine or polysorbate 80.
  • Any serious active disease (including clinically significant infection that is chronic, recurrent, or active) or co-morbid condition, which, in the opinion of the Investigator, could interfere with the safety, the compliance with the study or with the interpretation of the results.
  • Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results.

Locations & Contacts

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available

Connecticut

New Haven
Yale University
Status: Active
Contact: Laura Leary
Phone: 203-800-1969
Email: laura.leary@yale.edu

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Trial Objectives and Outline

The study duration for an individual patient will include a screening period for inclusion of up to 21 days. The treatment period may continue until disease progression, unacceptable adverse reaction, or other reason for discontinuation. After study treatment discontinuation an end of treatment (EOT) visit will be done at approximately 30 days after last study treatment component administration to assess safety. If the last ADA sample is positive or inconclusive, additional ADA will be sampled 3 months later. No further ADA will be sampled, even if this 3-month sample is positive. Patients who discontinue treatment for reasons other than progression of disease will be followed every month until progression or initiation of subsequent therapy, for a maximum of one year, whichever comes first.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Sanofi Aventis

Trial IDs

Primary ID TCD14079
Secondary IDs NCI-2015-00804, U1111-1155-7484
Clinicaltrials.gov ID NCT02283775