A Phase I Study Of Panobinostat/Lenalidomide/Bortezomib/Dex for Relapsed And Relapsed/Refractory Multiple Myeloma
NCT01965353 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2021-09-05
Summary
This research study is evaluating an investigational drug called "panobinostat" (LBH589) in combination with the standard agents lenalidomide, bortezomib, and dexamethasone as a possible treatment for multiple myeloma.
Conditions
- Multiple Myeloma in Relapse
Interventions
- DRUG
-
Panobinostat
\- Panobinostat - single oral dose on days 1, 3, 5, 8, 10 and 12 and followed by a 9-day rest period.
- DRUG
-
Dexamethasone - oral dose on Days 1, 2, 4, 5, 8, 9, 11 and 12 followed by a 9-day rest period
- DRUG
-
Lenalidomide - daily oral dose on Days 1-14 followed by 7-day rest period
- DRUG
-
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
Sponsors & Collaborators
- collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
Jacob Laubach, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-10-31
- Primary Completion
- 2019-03-31
- Completion
- 2021-09-30
Countries
- United States
Study Locations
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