Elotuzumab in Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance for Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02655458|
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : August 18, 2017
The purpose of this study is to explore the combination of Elotuzumab in combination with autologous stem cell transplantation and lenalidomide maintenance to see what side effects it may have and how well it works for the treatment of symptomatic multiple myeloma diagnosed and treated with induction therapy in the past year.
Induction therapy is the first phase of treatment for multiple myeloma. The goal of induction therapy for multiple myeloma is to reduce the number of plasma cells in the bone marrow and the proteins that the plasma cells produce. Induction therapy is usually given for 3-4 weeks.
An autologous peripheral blood stem cell transplant is a procedure in which immature "stem cells" are collected and stored for future use. A high dose of chemotherapy is given to the patient to destroy myeloma cells, and the patient's stem cells are replaced.
The investigational drug in this program is elotuzumab. Elotuzumab is known as BMS-901608. Elotuzumab is a manufactured protein directed against a target found on multiple myeloma cells. Lenalidomide is currently approved for patients with multiple myeloma. Melphalan and cyclophosphamide, the drugs used during stem cell collection and transplant, are also approved by the U.S. FDA. Melphalan is an FDA-approved chemotherapy for multiple myeloma and is used as high-dose treatment prior to stem cell transplantation. Cyclophosphamide is an FDA-approved chemotherapy that may be used, either alone, or in combination with other drugs to treat multiple myeloma.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Elotuzumab Drug: Lenalidomide Other: autologous PBMC reconstitution Other: ASCT||Phase 1|
This is a Phase 1b, open-label, trial investigating elotuzumab and autologous PBMC reconstitution with auto-SCT consolidation therapy and lenalidomide maintenance. Fifteen patients will be enrolled in this study.
This study is based on the hypothesis that the addition of Elotuzumab and autologous PBMC reconstitution to standard-of-care auto-SCT and lenalidomide maintenance will be safe and feasible. Furthermore, we hypothesize that Elotuzumab and PBMC reconstitution will target residual myeloma cells, enhance NK cell activation and ADCC, and promote tumor-specific humoral and cellular immune responses against myeloma cells, resulting in long-term maintenance of the minimal residual disease state.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of Elotuzumab in Combination With Autologous Stem Cell Transplantation and Lenalidomide Maintenance for Multiple Myeloma|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||July 13, 2017|
|Actual Study Completion Date :||July 13, 2017|
Experimental: autologous PBMC reconstitution, Elotuzumab, Lenalidomide
Max number of cycles is 12. Elotuzumab will be administered IV 20 mg/kg on Day 1 of each cycle. Lenalidomide dosing will start with cycle 4 at 10 mg orally daily days 1-21.
The following must also be administered before any elotuzumab:
Dexamethasone 8 mg IV (on the day of elotuzumab infusion 45-90 mins prior to the start of infusion), the following 30 - 90 minutes prior to start of infusion: H1 blocker: diphenhydramine (25 - 50 mg po or IV) or equivalent, H2 blocker: ranitidine (50 mg IV) or equivalent (adjusted for renal failure as indicated), acetaminophen (650 - 1000 mg po).
Other Name: Empliciti
On the days of elotuzumab administration, the dose of lenalidomide is to be administered at least 2 hours after completion of elotuzumab dosing. Aspirin 81 mg PO daily will also be prescribed for DVT prophylaxis.
Other Name: Revlimid
Other: autologous PBMC reconstitution
Autologous peripheral blood mononuclear cell collection and reconstitution. PBMC will be collected from patients by standard apheresis procedures. Up to 25 ml of autologous plasma will also be recovered for dilution of cryopreserved products (if necessary). For reconstitution, Patients will be pre-medicated as per each institution's standard protocols prior to reinfusion of PBMC products. Patient ID will be checked and verified by nursing staff and the products will be re-infused by continuous intravenous infusion pump. Patient vital signs will be monitored every 15 minutes for the duration of the procedure as per standard reinfusion protocol.
Autologous peripheral blood stem cell transplantation. (stem cells from the patient's own marrow are "harvested," stored and then returned to the body (engrafted). To be done as part of standard of care.
Other Name: auto-SCT consolidation therapy
- Incidence of completion of treatment [ Time Frame: up to 24 months ]Safety and tolerability will be measured by the number of evaluable patients who complete the treatment protocol.
- IFE level [ Time Frame: up to 24 months ]Immunofixation Serum Test (IFE) level
- sFLC level [ Time Frame: up to 24 months ]Serum Free Light Chain analysis (sFLC) level
- Bone marrow MRD analysis [ Time Frame: up to 24 months ]Bone marrow disease (MRD) is the name for small numbers of leukaemic cells in the bone marrow
- Progression-Free Survival [ Time Frame: up to 24 months ]number of participants at 24 months who are progression-free
- CyTOF mass cytometry [ Time Frame: up to 24 months ]Immune cell reconstitution will be assessed by Cytometry by Time-Of-Flight (CyTOF) mass cytometry. This method quantifies and characterizes all cellular immune compartments.
- SPEP level [ Time Frame: up to 24 hours ]Serum protein electrophoresis (SPEP) level
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): NCT02655458
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Hearn Jay Cho, MD||Icahn School of Medicine at Mount Sinai|