Study of Bortezomib,Lenalidomide,Dexamethasone & Elotuzumab in Newly Diagnosed MM
|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: NCT02375555|
Recruitment Status : Active, not recruiting
First Posted : March 2, 2015
Last Update Posted : February 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Lenalidomide Drug: Elotuzumab Drug: Bortezomib Drug: Dexamethasone Procedure: Stem Cell Mobilization||Phase 2|
This research study is a Phase II clinical trial testing the safety and effectiveness of an investigational drug (in this case elotuzumab) in combination with lenalidomide, bortezomib and dexamethasone to learn more about the side effects of this regimen and whether it is effective in newly diagnosed multiple myeloma.
"Investigational" means that the drug elotuzumab and the combination of this agent with lenalidomide, bortezomib, and dexamethasone are being studied. It also means that the the U.S. Food and Drug Administration (FDA) has not yet approved elotuzumab for the treatment of cancer. The drugs, lenalidomide, bortezomib, and dexamethasone are approved by the FDA. Participants in this trial will have the option to undergo autologous stem cell transplantation (ASCT) following initial therapy with elotuzumab, lenalidomide, bortezomib, and dexamethasone. ASCT is a standard of care in the treatment of multiple myeloma. All participants, including those who undergo ASCT and those who choose not to, will receive what is referred to as "maintenance therapy" - or continuous treatment - after the initial cycles of treatment with elotuzumab, lenalidomide, bortezomib, and dexamethasone. The specific maintenance regimen will be determined by risk category.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single Arm, Phase 2a Study of Bortezomib, Lenalidomide, Dexamethasone and Elotuzumab in Newly Diagnosed Multiple Myeloma|
|Actual Study Start Date :||May 7, 2015|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||June 2022|
Experimental: Elotuzumab, lenalidomide, bortezomib, and dexamethasone
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.
Subjects may elect to stop E-RVD Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.
- The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.
Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
Other Name: Revlimid®
Other Name: HuLuc63
Other Name: Velcade
Procedure: Stem Cell Mobilization
- Overall Response Rate [ Time Frame: average of 12 weeks ]To estimate the response rate after 4 cycles of induction therapy in subjects treated with E-RVD
- Overall response rate (ORR) [ Time Frame: average of 24 weeks ]
- Number of adverse events as a measure of safety profile [ Time Frame: average of 24 weeks ]
- Progression free survival (PFS) rate [ Time Frame: 2 years ]
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): NCT02375555
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, New Jersey|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|United States, North Carolina|
|Levine Cancer Institute|
|Charlotte, North Carolina, United States, 28204|
|United States, Virginia|
|Virginia Cancer Specialists|
|Fairfax, Virginia, United States, 22031|
|Principal Investigator:||Jacob P. Laubach, MD||Dana-Farber Cancer Institute|