Combination Therapy of Lenalidomide/Bortezomib/Dexamethasone and Panobinostat in Transplant Eligible New Diagnosed Multiple Myeloma (MM) Patients
The goal of this clinical research study is to find the highest tolerable dose of the drug panobinostat that can be given in combination with the drugs Velcade (bortezomib), Revlimid (lenalidomide), and Decadron (dexamethasone) to patients with MM. The safety of this drug combination will also be studied.
Panobinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die.
Bortezomib is designed to block a protein that causes cells to grow. This may cause cancer cells to die.
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may slow the growth of cancer cells.
Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to MM patients in combination with other chemotherapy to treat cancer.
Behavioral: Symptom Questionnaire
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/Ib Trial of the Efficacy and Safety of Combination Therapy of Lenalidomide/Bortezomib/Dexamethasone and Panobinostat in Transplant Eligible Patients With Newly Diagnosed Multiple Myeloma (MM)|
- Maximum Tolerated Dose (MTD) of Panobinostat with Bortezomib, Lenalidomide, and Dexamethasone [ Time Frame: First 21 days of study drug administration (continuous dosing) ] [ Designated as safety issue: Yes ]Maximum tolerated dose (MTD) defined as highest dose level in which 6 participants have less than 2 instances of dose limiting toxicities (DLT). Toxicities graded in severity according to guidelines outlined in NCI-CTCAE version 4.0. Hematologic and non-hematologic DLTs defined differently, and will be based on experiences that occur during the first cycle of study drug administration.
|Study Start Date:||February 2013|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Experimental: Panobinostat + Bortezomib + Lenalidomide + Dexamethasone
Induction Starting Doses: Lenalidomide 25 mg orally daily Days 1-14; Bortezomib 1.3 mg/m2 intravenous (IV) daily Days 1, 4, 8 and 11; Dexamethasone 20 mg orally daily Days 1, 2, 4, 5, 8, 9, 11, 12 and Panobinostat orally 10 mg three times a week, for weeks 1 and 2. Four 21-day Induction cycles.
Symptom Questionnaire completed on Day 8 of Cycle 1 and first Day of each subsequent Cycle.
Starting dose: 10 mg by mouth on Days 1, 3, 5, 8, 10, and 12 for 2 weeks with 1 week of rest at the end of each cycle.
Phase 2 Starting Dose: Maximum tolerated dose (MTD) from Induction Phase.
Other Name: LBH589BDrug: Bortezomib
Starting Dose: 1.3 mg/m2 by vein daily on days 1, 4, 8 and 11 of Cycles 1 - 8.
Other Names:Drug: Lenalidomide
Starting dose: 25 mg by mouth daily on days 1-14 followed by 7-day rest every 21 days.
Maintenance dose: Last tolerated dose from Induction Phase on Days 1 - 21 every 28 days.
Other Names:Drug: Dexamethasone
20 mg by mouth daily on Days 1, 2, 4, 5, 8, 9, 11, 12 of Cycles 1 - 8.
Maintenance dose: Last tolerated dose from Induction Phase on Days 1, 8, 15, 21 of a 28 day cycle.
Other Name: DecadronBehavioral: Symptom Questionnaire
Completed on Day 8 of Cycle 1 and first Day of each subsequent Cycle.
Other Name: Survey
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01440582
|Contact: Jatin J. Shah, MD||713-792-2860|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jatin J. Shah, MD||M.D. Anderson Cancer Center|