A Study of Elotuzumab With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed Multiple Myeloma
|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: NCT02718833|
Recruitment Status : Active, not recruiting
First Posted : March 24, 2016
Last Update Posted : March 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Elotuzumab Drug: Pomalidomide Drug: Bortezomib Drug: Dexamethasone||Phase 2|
This research study is a phase II clinical trial, the investigators are studying the safety and response rate of the combinations of elotuzumab, pomalidomide, bortezomib, dexamethasone (elo-PVD).
The FDA (the U.S. Food and Drug Administration) has approved each of those drugs elotuzumab, pomalidomide, bortezomib, dexamethasone as a treatment option for Refractory or relapsed multiple myeloma.
Pomalidomide is a drug that changes that enhances or suppresses your immune systems reaction to a stimulus.This change may help the body destroy tumor cells. Bortezomib is an inhibitor that targets how cells dispose of unneeded proteins. By blocking this process, bortezomib can help destroy unwanted cells. Dexamethasone is a steroid, that helps prevent inflammation in a wide variety of organs and acts against myeloma cells. Elotuzumab is a monoclonal antibody, Elotuzumab targets a protein that is highly common on the surface of multiple myeloma cells called SLAMF7.
The combination of the drugs may provide an unique approach for treating the disease.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Elotuzumab in Combination With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed and Refractory Multiple Myeloma|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2023|
Experimental: Elotuzumab, pomalidomide, bortezomib, dex
Each cycle is 28 days.
Elotuzumab will be administered by intravenous infusion. For cycles 1-2, elotuzumab will ge given weekly. For cycles 3-8, elotuzumab will be given every other week. For cycles 9+, elotuzumab will be given on day 1.
Pomalidomide will be given orally on days 1-21.
Bortezomib will be given weekly subcutaneously on days 1, 8, 15.
Dexamethasone will be given as a combination orally and intravenously.
Other Name: Empliciti
Other Name: Pomalyst
Other Name: Velcade
Other Name: Decadron
- Overall response rate by International Myeloma Working Group criteria. [ Time Frame: 2 years ]To evaluate the objective response rate (partial response or better) of elotuzumab in combination with pomalidomide, bortezomib, and dexamethasone in patients with relapsed and refractory multiple myeloma and who have received at least two prior therapies and are relapsed and/or refractory to both lenalidomide and bortezomib.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]
- Progression Free Survival [ Time Frame: 2 Years ]To evaluate the progression free survival (PFS) of elotuzumab-PVD.
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): NCT02718833
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Mass General/North Shore Cancer Center|
|Danvers, Massachusetts, United States, 01923|
|Newton, Massachusetts, United States, 02462|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Andrew J Yee, MD||Massachusetts General Hospital|