This is a multicenter, open-label, Phase 1b study to determine the recommended dose and regimen of durvalumab either as monotherapy or in combination with POM with or without low dose dex in subjects with RRMM. The study will consist of a dose-finding portion as well as a parallel dose-expansion portion to determine the optimal dose and regimen. On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Local Institution - 102
Baltimore, Maryland, United States
Local Institution - 114
Boston, Massachusetts, United States
Local Institution - 108
Boston, Massachusetts, United States
Local Institution - 115
Boston, Massachusetts, United States
Local Institution - 105
New York, New York, United States
Local Institution - 106
Charlotte, North Carolina, United States
Local Institution - 110
Cleveland, Ohio, United States
Local Institution - 107
Milwaukee, Wisconsin, United States
Local Institution - 201
Calgary, Alberta, Canada
Local Institution - 601
Lille, France
...and 12 more locations
Dose-limiting Toxicities (DLTs)
Number of participants with DLTs in the first cycle of treatment
Time frame: Approximately 1 month
Adverse Events (AEs)
Number of participants with adverse events
Time frame: Up to approximately 2 year
Overall response rate (ORR)
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria
Time frame: Up to approximately 2 year
Time to response (TTR)
Time from first dose to the first documentation of response (Partial Response \[PR\] or greater)
Time frame: Up to approximately 2 year
Duration of response (DOR)
Is defined as time from the earliest date of documented response (partial response (PR) or better) to the earliest date when disease progression was confirmed
Time frame: Up to approximately 2 year
Pharmacokinetics- Cmax
Maximum observed concentration
Time frame: Up to approximately 1 year
Pharmacokinetics- AUC
Area under the concentration-time curve
Time frame: Up to approximately 1 year
Pharmacokinetics- Tmax
Time to maximum concentration
Time frame: Up to approximately 1 year
Pharmacokinetics- t1/2
Terminal elimination half-life
Time frame: Up to approximately 1 year
Pharmacokinetics- CL/F
Apparent total body clearance
Time frame: Up to approximately 1 year
Pharmacokinetics- Vz/F
Volume of distribution
Time frame: Up to approximately 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.