SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients
- Conditions
- Plasma Cell Myeloma
- Interventions
- Registration Number
- NCT02283775
- Lead Sponsor
- Sanofi
- 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 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).
- 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, 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PomdeSAR Isatuximab SAR650984 Part A: Isatuximab (escalating dose) on Day 1, 8, 15, and 22, then Day 1 and 15 + pomalidomide 4 mg on Day 1 to 21 + dexamethasone 40 mg (20 mg in patients of 75 years or older) on Day 1, 8, 15, 22 in 28-day cycles up to disease progression Part B: Isatuximab 10 mg/kg on Day 1, 8, 15, and 22, then Day 1 and 15 + pomalidomide 4 mg on Day 1 to 21 + dexamethasone 40 mg (20 mg in patients of 75 years or older) on Day 1, 8, 15, 22 in 28-day cycles up to disease progression PomdeSAR Pomalidomide Part A: Isatuximab (escalating dose) on Day 1, 8, 15, and 22, then Day 1 and 15 + pomalidomide 4 mg on Day 1 to 21 + dexamethasone 40 mg (20 mg in patients of 75 years or older) on Day 1, 8, 15, 22 in 28-day cycles up to disease progression Part B: Isatuximab 10 mg/kg on Day 1, 8, 15, and 22, then Day 1 and 15 + pomalidomide 4 mg on Day 1 to 21 + dexamethasone 40 mg (20 mg in patients of 75 years or older) on Day 1, 8, 15, 22 in 28-day cycles up to disease progression PomdeSAR Dexamethasone Part A: Isatuximab (escalating dose) on Day 1, 8, 15, and 22, then Day 1 and 15 + pomalidomide 4 mg on Day 1 to 21 + dexamethasone 40 mg (20 mg in patients of 75 years or older) on Day 1, 8, 15, 22 in 28-day cycles up to disease progression Part B: Isatuximab 10 mg/kg on Day 1, 8, 15, and 22, then Day 1 and 15 + pomalidomide 4 mg on Day 1 to 21 + dexamethasone 40 mg (20 mg in patients of 75 years or older) on Day 1, 8, 15, 22 in 28-day cycles up to disease progression
- Primary Outcome Measures
Name Time Method Incidence of grade ≥3 IARs according to the NCI-CTC version 4.03 grade scaling Part B: Up to 8 weeks Dose Limiting Toxicities (DLTs) Part A: Up to 4 weeks Number of patients with adverse events and clinically significant changes in laboratory tests and vital signs according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 grade scaling Part A: Up to 30 days for patients experiencing progressive disease and up to one year or the initiation of a new line of treatment for patients leaving the study for reasons other than progressive disease
- Secondary Outcome Measures
Name Time Method Immune response: levels of human anti-human antibodies (ADA) Part A: Up to approximately 8 months; Part B: Up to approximately 10 months Overall response rate Part A: Up to approximately 8 months; Part B: Up to approximately 10 months Infusion duration Part B: Up to approximately 10 months Pharmacokinetics: Partial area under the serum concentration time curve (AUC) Part A: Up to approximately 10 months Pharmacokinetics: maximum observed concentration (Cmax) Part A: Up to approximately 10 months Duration of response - Time Part A: Up to approximately 8 months; Part B: Up to approximately 10 months Clinical Benefit rate Part A: Up to approximately 8 months; Part B: Up to approximately 10 months Safety of isatuximab administration from fixed volume Part B: Up to 30 days for patients experiencing progressive disease and up to one year or the initiation of a new line of treatment for patients leaving the study for reasons other than progressive disease Relationship between clinical effect and CD38 receptor density Part A: Up to approximately 8 months
Trial Locations
- Locations (13)
Investigational Site Number 840011
🇺🇸Decatur, Illinois, United States
Investigational Site Number 840015
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number 840005
🇺🇸Seattle, Washington, United States
Investigational Site Number 840018
🇺🇸New Haven, Connecticut, United States
Investigational Site Number 840016
🇺🇸Charleston, South Carolina, United States
Investigational Site Number 840006
🇺🇸Duarte, California, United States
Investigational Site Number 840010
🇺🇸Chapel Hill, North Carolina, United States
Investigational Site Number 840001
🇺🇸Scottsdale, Arizona, United States
Investigational Site Number 840004
🇺🇸Boston, Massachusetts, United States
Investigational Site Number 840104
🇺🇸Boston, Massachusetts, United States
Investigational Site Number 840014
🇺🇸Canton, Ohio, United States
Investigational Site Number 840003
🇺🇸Charlotte, North Carolina, United States
Investigational Site Number 840017
🇺🇸Milwaukee, Wisconsin, United States