An investigational immuno-therapy study of Nivolumab, Pomalidomide andDexamethasone combinations in patients with Multiple Myeloma
Phase 1
- Conditions
- relapsed and refractory Multiple MyelomaMedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-005699-21-SE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 417
Inclusion Criteria
- Refractory or relapsed and refractory multiple myeloma
- Measurable disease
- Have received = 2 lines of prior therapy which must have included an
immune modulatory drug (IMiD) and a proteasome inhibitor alone or in
combination
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 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 292
Exclusion Criteria
- Solitary bone or extramedullary plasmacytoma disease only
- Active plasma cell leukemia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to compare progression free survival (PFS) between N-Pd and Pd arms, by investigator;Secondary Objective: • To estimate overall survival (OS) within N-Pd and Pd arms<br>• To assess the time to objective response (TTR) within N-Pd and Pd arms by investigator<br>• To assess the duration of objective response (DOR) within N-Pd and Pd arms by investigator<br>• To compare ORR between N-Pd and Pd arms, by investigator.<br>;Primary end point(s): 1. Progression free survival (PFS) by investigator;Timepoint(s) of evaluation of this end point: 1. Approximately 47 months from the time of 1st patient randomization
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1.To assess the time to objective response (TTR) by Investigator<br>2.To assess the duration of objective response (DOR) by investigator<br>3. Objective response rate (ORR) by investigator<br>4. Overall Survival (OS)<br><br><br><br>;Timepoint(s) of evaluation of this end point: 1, Approximately 47 months from the time of 1st patient randomization<br>2. Approximately 47 months from the time of<br>1st patient randomization<br>3. Approximately 47 months from the time of<br>1st patient randomization<br>4. Approximately 47 months from the time of<br>1st patient randomization<br>