Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK-3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (MK-3475-183/KEYNOTE-183)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02576977 |
Recruitment Status :
Terminated
(The study was terminated early due to business reasons)
First Posted : October 15, 2015
Results First Posted : August 2, 2019
Last Update Posted : October 8, 2021
|
Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | October 14, 2015 | ||||||
First Posted Date ICMJE | October 15, 2015 | ||||||
Results First Submitted Date ICMJE | July 8, 2019 | ||||||
Results First Posted Date ICMJE | August 2, 2019 | ||||||
Last Update Posted Date | October 8, 2021 | ||||||
Actual Study Start Date ICMJE | October 19, 2015 | ||||||
Actual Primary Completion Date | July 9, 2018 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
|
||||||
Original Primary Outcome Measures ICMJE |
Progression Free Survival (PFS) [ Time Frame: Up to 33 months ] | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
|
||||||
Original Secondary Outcome Measures ICMJE |
Overall Survival (OS) [ Time Frame: Up to 33 months ] | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK-3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (MK-3475-183/KEYNOTE-183) | ||||||
Official Title ICMJE | A Phase III Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (KEYNOTE 183) | ||||||
Brief Summary | The purpose of this study is to compare the efficacy of pomalidomide and low dose dexamethasone with pembrolizumab (MK-3475) to that of pomalidomide and low dose dexamethasone without pembrolizumab in terms of Progression-Free Survival (PFS) in participants with refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least 2 lines of prior treatment. The study's 2 primary hypotheses are: 1. Pembrolizumab in combination with pomalidomide and low dose dexamethasone prolongs PFS as assessed by Clinical Adjudication Committee (CAC) blinded central review using International Myeloma Working Group Criteria for Response Assessment in Multiple Myeloma (IMWG) criteria compared to treatment with pomalidomide and low dose dexamethasone standard of care (SOC) alone. 2. Pembrolizumab in combination with pomalidomide and low dose dexamethasone prolongs OS compared to treatment with pomalidomide and low dose dexamethasone (SOC) alone. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
Condition ICMJE | Multiple Myeloma | ||||||
Intervention ICMJE |
|
||||||
Study Arms ICMJE |
|
||||||
Publications * |
|
||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE |
251 | ||||||
Original Estimated Enrollment ICMJE |
300 | ||||||
Actual Study Completion Date ICMJE | July 16, 2020 | ||||||
Actual Primary Completion Date | July 9, 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender ICMJE |
|
||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | Australia, Canada, France, Germany, Israel, Italy, Japan, New Zealand, Norway, Spain, United States | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02576977 | ||||||
Other Study ID Numbers ICMJE | 3475-183 2015-002509-13 ( EudraCT Number ) 163146 ( Registry Identifier: JAPAN-CTI ) MK-3475-183 ( Other Identifier: Merck Protocol Number ) KEYNOTE-183 ( Other Identifier: Merck ) |
||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
|
||||||
IPD Sharing Statement ICMJE |
|
||||||
Current Responsible Party | Merck Sharp & Dohme LLC | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Merck Sharp & Dohme LLC | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
|
||||||
PRS Account | Merck Sharp & Dohme LLC | ||||||
Verification Date | September 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |