Induction Therapy for Multiple Myeloma With Carfilzomib, Lenalidomide,Dexamethasone,Panobinostat
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|ClinicalTrials.gov Identifier: NCT02802163|
Recruitment Status : Withdrawn (study drug unavailable)
First Posted : June 16, 2016
Last Update Posted : April 25, 2017
The purpose of this study for Phase l is to determine the maximum tolerated dose of panobinostat given in combination with carfilzomib, lenalidomide, and dexamethasone in 28-day cycles as induction (initial) therapy to participants with newly diagnosed multiple myeloma.
In Phase ll, investigators will evaluate the safety (side effects) and efficacy (effectiveness) of panobinostat in combination with carfilzomib, lenalidomide, and dexamethasone.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Panobinostat Drug: Carfilzomib Drug: Lenalidomide Drug: Dexamethasone||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I-II Study of Carfilzomib, Lenalidomide, Dexamethasone, and Panobinostat, Ca-R-Pa-Diem, as Induction Therapy for Newly Diagnosed, Untreated, Transplant-Eligible, Multiple Myeloma Patients|
|Estimated Study Start Date :||June 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Combination Therapy
Combination Therapy: Panobinostat, Carfilzomib, Lenalidomide, Dexamethasone (Ca-R-Pa-Diem) . Participants will receive up to 8 cycles of the combination as induction after which will proceed with consolidation therapy with transplant as per institutional standards. After transplant, participants receive maintenance with panobinostat/lenalidomide. The maintenance dose and schedule of panobinostat will be same given during induction for 1 year. The maintenance dose of lenalidomide will be 10 mg given for 21 days of 28 days cycle until disease progression.
Induction Phase: Panobinostat (dose escalation beginning at 10 mg) will be administered 3 times a week (TIW) by mouth every other week starting on day 1 of each cycle.
Maintenance Phase: Panobinostat will be administered TIW by mouth every other week starting on day 1 of each cycle. The dose of panobinostat during maintenance phase will be the same dose taken during cyce 8 of induction phase.
Induction Phase: Carfilzomib will be administered at 20 mg/m^2 on Cycle 1 Day 1. Beginning on Cycle 1 Day 2 the carfilzomib dose will be according to the assigned level of 27 mg/m^2 or 36 mg/m^2. Carfilzomib will be administered twice weekly IV on Days 1,2, 8,9,15, and 16.
Other Name: Kyprolis
Induction Phase: Lenalidomide (25 mg) will be administered once-daily by mouth on Days 1-21, 25.
Maintenance Phase: Lenalidomide (10 mg) will be administered once-daily by mouth on days 1-21.
Other Name: Revlimid
Induction Phase: Dexamethasone (20 mg) will be administered twice weekly by mouth or by IV on Days 1,2, 8, 9, 15, and 16.
- Phase I: Maximum Tolerated Dose (MTD) [ Time Frame: Up to 8 months ]MTD of the Ca-R-Pa-Diem given in combination to newly diagnosed Multiple Myeloma patients.
- Stringent Complete Remission (sCR) Rate after 4 and 8 Cycles of Treatment [ Time Frame: Up to 8 months ]Response rates by International Myeloma Working Group Uniform Response Criteria (IMWG-URC). Complete Response (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. sCR: CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
- Phase II: Overall Response Rate (ORR) [ Time Frame: Up to 36 months ]Overall response rate will be the proportion of participants who achieved Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR). Response rate determined by IMWG-URC will be calculated based on the number of participants with each of response categories (sCR, CR, VGPR, PR, and progressive disease) at each treatment cycle.
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): NCT02802163
|Principal Investigator:||Melissa Alsina, M.D.||H. Lee Moffitt Cancer Center and Research Institute|