Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03030261|
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : September 29, 2020
Based on the need to improve outcomes post second autologous stem cell transplant (ASCT) for multiple myeloma (MM) and the benefits seen of maintenance treatment following initial ASCT, the natural next step is to evaluate maintenance/continuation therapy following second ASCT.
Pomalidomide is active against MM cells refractory to both bortezomib and lenalidomide, making it an ideal choice for continuation therapy following second ASCT. Adding elotuzumab may increase efficacy and also the durability of responses which is essential to improving outcomes following second ASCT.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma in Relapse||Drug: Elotuzumab Drug: Pomalidomide Drug: Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma|
|Actual Study Start Date :||November 22, 2017|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||February 28, 2026|
Experimental: Elotuzumab + Pomalidomide + Dexamethasone
During continuation therapy, elotuzumab will be administered on a 28-day cycle as follows: on Days 1 and 15 for Cycles 1-6 and on Day 1 for Cycles 7+. For Cycles 1-6 elotuzumab will be administered intravenously at a dose of 10 mg/kg. For Cycles 7+ elotuzumab will be administered at a dose of 20 mg/kg.
Other Name: Empliciti
During continuation therapy, pomalidomide will be taken by mouth daily on Days 1-21 of each 28-day cycle at a starting dose of 2 mg. During continuation, pomalidomide may be dose escalated to 4 mg at the discretion of the treating physician if the 2 mg dose is tolerated.
Other Name: Pomalyst
During continuation therapy, dexamethasone will be taken by mouth at a starting dose of 40 mg. It will be given on a 28-day cycle as follows: on Days 1 and 15 for Cycles 1-6 and on Day 1 only for Cycles 7+. Sufficient quantity of drug for one cycle of therapy will be prescribed to the patient at a time.
Other Name: Decadron
- Event-free survival (EFS) rate [ Time Frame: 1 year ]-Event-free survival (EFS) will be defined as time from ASCT to disease progression, relapse, or death, whichever occurs first. Patients who are removed from study therapy prior to any of these events occurring will be censored at the time of initiation of subsequent anti-myeloma treatment.
- Overall response rate (ORR) [ Time Frame: 1 year ]-Overall response rate (ORR) will be defined as the proportion of evaluable patients meeting the criteria for partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR).
- Complete response rate (CRR) [ Time Frame: 1 year ]
- Complete response rate (CRR) will be defined as the proportion of evaluable patients meeting the criteria complete (CR) or stringent complete response (sCR)
Stringent complete response (sCR) requires all of the following:
- CR as defined below
- Normal free light chain ratio (0.26-1.65)
- Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence
Complete response (CR) requires all of the following:
- Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine
- If serum and urine monoclonal protein are unmeasurable, Normal free light chain ratio (0.26-1.65)
- <5% plasma cells in the bone marrow
- Disappearance of soft tissue plasmacytoma
- Patients who do not meet the definition of CR based solely on residual monoclonal protein on serum electrophoresis and/or immunofixation, but are MRD-negative as described above, will also be considered CR.
- Minimal residual disease negative (MRD-negative) rate [ Time Frame: 1 year ]-Minimal residual disease (MRD) testing should be performed using clonoSEQ next-generation sequencing technology . Patients will be classified as MRD-negative or MRD-positive based on the current detection limits of the test (1 MM cell per 1x10^6 cells).
- Event-free survival (EFS) [ Time Frame: Up to 5 years ]-Event-free survival (EFS) will be defined as time from ASCT to disease progression, relapse, or death, whichever occurs first. Patients who are removed from study therapy prior to any of these events occurring will be censored at the time of initiation of subsequent anti-myeloma treatment.
- Progression-free survival (PFS) [ Time Frame: Up to 5 years post completion of treatment ]-Progression-free survival (PFS) will be defined as time from ASCT to disease progression or relapse. Any patient who expires or withdraws prior to disease progression or relapse will be censored at last follow-up. Patients who are removed from study therapy prior to progression or relapse will be censored at the time of initiation of subsequent anti-myeloma treatment.
- Overall survival (OS) [ Time Frame: Up to 5 years post completion of treatment ]-Overall survival (OS) will be defined as time from ASCT to death due to any causes. Patients who are alive at the time of data analyses will be censored on the last known alive date. Patients who are removed from study therapy prior death will be censored at the time of initiation of subsequent anti-myeloma treatment.
- Toxicity of regimen as measured by frequency of adverse events per the number of participants treated [ Time Frame: Up to 30 days following completion of treatment (estimated to be 106 weeks) ]-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
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): NCT03030261
|Contact: Ravi Vij, M.D.||(314) email@example.com|
|United States, Colorado|
|Colorado Blood Cancer Institute (Sarah Cannon)||Not yet recruiting|
|Denver, Colorado, United States, 80218|
|Contact: Jeffrey V Matous, M.D. 720-754-4800|
|Principal Investigator: Jeffrey V Matous, M.D.|
|Sub-Investigator: Scott I Bearman, M.D.|
|Sub-Investigator: Alireza Eghtedar, M.D.|
|Sub-Investigator: Tara K Gregory, M.D.|
|Sub-Investigator: Michael B Maris, M.D.|
|Sub-Investigator: Peter A McSweeney, M.D.|
|Sub-Investigator: Richard Nash, M.D.|
|Sub-Investigator: Marcello Rotta, M.D.|
|Sub-Investigator: Michael T Tees, M.D.|
|Sub-Investigator: Henning H Schade, M.D.|
|United States, Georgia|
|Emory Winship Cancer Institute||Not yet recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Ajay Nooka, M.D. 404-778-1900|
|Principal Investigator: Ajay Nooka, M.D.|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Ravi Vij, M.D. 314-454-8323 firstname.lastname@example.org|
|Principal Investigator: Ravi Vij, M.D.|
|University Health Network - Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Christine Chen, M.D. 416-946-2827 Christine.Chen@uhn.ca|
|Principal Investigator: Christine Chen, M.D.|
|Sub-Investigator: Vishal Kukreti, M.D.|
|Sub-Investigator: Suzanne Trudel, M.D.|
|Sub-Investigator: Rodger Tiedemann, M.D.|
|Sub-Investigator: Anca Prica, M.D.|
|Sub-Investigator: Donna Reece, M.D.|
|Principal Investigator:||Ravi Vij, M.D.||Washington University School of Medicine|