A Phase I Study Of Panobinostat/Lenalidomide/Bortezomib/Dex for Relapsed And Relapsed/Refractory Multiple Myeloma (PanRVD)
Multiple Myeloma in Relapse
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase I Open Label Study Of Panobinostat In Combination With Lenalidomide, Bortezomib, And Dexamethasone In Patients With Relapsed And Relapsed/Refractory Multiple Myeloma|
- MTD (Maximum Tolerated Dose) of panobinostat in combination with RVD [ Time Frame: 2 Years ]
- Recommended dose of the combination for Phase 2 studies in participants with relapsed and relapsed/refractory multiple myeloma (MM) with SC bortezomib. [ Time Frame: 2 Years ]
- Response to pan-RVD (minimal response or better [ Time Frame: 2 Years ]
- Progression-free survival (PFS) [ Time Frame: 2 Years ]
- Duration of response [ Time Frame: 2 Years ]
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||August 2019|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Panobinostat - single oral dose on days 1, 3, 5, 8, 10 and 12 and followed by a 9-day rest period.
Each cycle of treatment will consist of 21 days. Accrual to the next higher dose level will not occur until the safety and tolerability of the prior dose level(s) has been determined at the end of the first cycle
- Panobinostat - single oral dose on days 1, 3, 5, 8, 10 and 12 and followed by a 9-day rest period.Drug: Dexamethasone
Dexamethasone - oral dose on Days 1, 2, 4, 5, 8, 9, 11 and 12 followed by a 9-day rest periodDrug: Lenalidomide
Lenalidomide - daily oral dose on Days 1-14 followed by 7-day rest period
Other Name: RevlimidDrug: Bortezomib
Bortezomib - subcutaneous injection, on Days 1, 4, 8, and 11 followed by a 10-day rest period. At least 72 hours should elapse between bortezomib doses, but if needed an interval of 70 hours is permitted
Other Name: Velcade
In this research study, the participant will be given a study drug-dosing diary for each treatment cycle. Each treatment cycle lasts 21 days (3 weeks) . The diary will also include special instructions for taking the study drug(s).
The investigator are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have multiple myeloma, not everyone who participates in this research study will receive the same dose of the study drug. The dose each participant will get will depend on the number of participants who have been enrolled in the study before each participant and how well they have tolerated their doses.
Each treatment cycle will be 21 days long. The participant will have to come to the clinic on days 1, 4, 5, 8, 10 and 11 in Cycle 1 and on days 1, 4, 8 and 11 in Cycles 2 and beyond. Days 1 and 5 of Cycle 1 will take about 8 hours. Every other visit should take about 1-4 hours, however there is always the possibility that it could take longer.
- Panobinostat is a capsule that the participant will take three times a week for the first two the weeks of each cycle. Then participant will have one week off study medication.
- Bortezomib will be administered in clinic as a subcutaneous injection twice a week during the first two weeks of each 21 day cycle.
- Lenalidomide will be taken orally once daily on days 1-14 of each cycle.
- Dexamethasone will be taken orally on the days of and after bortezomib administration during Cycles 1-8, and on days 1, 8 and 15 for Cycles 9 and beyond.
Planned Follow-up: The investigators would like to monitor the participant's medical condition even after the participants are no longer participating in the study. The investigators would like to do this by calling the participants on the telephone once every 6 months to see how the participant is doing. Keeping in touch with the participant and checking on their condition helps the investigator look at the long-term effects of the research study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01965353
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Jacob Laubach, MD||Dana-Farber Cancer Institute|