Status:
COMPLETED
SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients
Lead Sponsor:
Sanofi
Conditions:
Plasma Cell Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 Mul...
Detailed Description
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,...
Eligibility Criteria
Inclusion
- 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.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
May 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2021
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02283775
Start Date
May 15 2015
End Date
May 26 2021
Last Update
July 9 2021
Active Locations (13)
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1
Investigational Site Number 840001
Scottsdale, Arizona, United States, 85054
2
Investigational Site Number 840006
Duarte, California, United States, 91010
3
Investigational Site Number 840018
New Haven, Connecticut, United States, 06520-8017
4
Investigational Site Number 840011
Decatur, Illinois, United States, 62526