1454GCC: Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02289222|
Recruitment Status : Terminated (Due to the inclusion of an IMid in combination with pembrolizumab, Study Sponsor terminated the study.)
First Posted : November 13, 2014
Results First Posted : August 1, 2018
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: MK-3475 Drug: Pomalidomide Drug: Dexamethasone||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||1454GCC: Phase I/II Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma|
|Actual Study Start Date :||December 30, 2014|
|Actual Primary Completion Date :||August 7, 2017|
|Actual Study Completion Date :||August 7, 2017|
Experimental: Pomalidomide, Dexamethasone & MK-3475
Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).
Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.
Other Name: Generic name: Pembrolizumab - Trade name: Keytruda
Pomalidomide is given at standard dose of 4 mg daily orally for 21 days
Other Name: Pomalyst, CC-4047, Actimid
Dexamethasone is given at 40 mg orally weekly
Other Name: Decadron
- The Number of Participants With Adverse Events [ Time Frame: 24 month ]Establish the safety and tolerability of Pomalidomide and Dexamethasone in combination with MK-3475
- PD-LI Expression On Myeloma Cells [ Time Frame: Tissue sample collection will take place before starting study therapy with MK-3475 at baseline and again at time of relapse as defined by the International Myeloma Working Group Response Criteria (Average of up to 24months) ]The identification of a biomarker for response by evaluating PD-1/PDL-1 expression in patients' bone marrow aspirate samples will be analyzed in order to help select patients for future anti-PD-1 therapy. The main exploratory biomarker analysis was to examine potential correlation between expression of PD-1 on T cells and PD-L1 on myeloma cells with clinical outcome using the following parameters: response rate focusing on responses ≥ very good partial response (VGPR) and PFS. SAS software (v.9.4; SAS Institute, Inc, Cary, NC) was used for statistical analyses.
- Time to Progression Free Survival (PFS) [ Time Frame: PFS assessments will take place after starting study therapy with MD-3475 and will continue until the start of a new anti-neoplastic therapy, disease progression, death, or the end of study up to an average of 24 months. ]PFS will be measured in all participants. Survival and PFS functions were estimated using the Kaplan-Meier method. The Cox regression model was used to assess the following plausible risk factors for OS and PFS: age, isotype, number of cycles of therapy, and cytogenetic profile.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289222
|United States, Maryland|
|Greenebaum Cancer Center at University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201-1592|
|Principal Investigator:||Ashraf Z Badros, M.B.,Ch.B||University of Maryland Greenebaum Cancer Center|