Lenalidomide, Thalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00966693|
Recruitment Status : Active, not recruiting
First Posted : August 27, 2009
Last Update Posted : July 11, 2017
The goal of the Phase I portion of this clinical research study is to find the highest tolerated dose of the combination of thalidomide, lenalidomide, and dexamethasone that can be given to patients with relapsed or refractory MM.
The goal of the Phase II portion of this study is to learn if the drug combination can help to control the disease.
The safety of the drug combination will be studied in both phases.
|Condition or disease||Intervention/treatment||Phase|
|Myeloma||Drug: Lenalidomide Drug: Thalidomide Drug: Dexamethasone||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Lenalidomide (Revlimid), Thalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma|
|Actual Study Start Date :||August 2009|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
Experimental: Lenalidomide + Thalidomide + Dexamethasone
Lenalidomide 15 mg daily by mouth on Days 1-21 followed by 7-day rest every 28 day cycle for Cycles 1-8. Thalidomide 100 mg daily by mouth on Days 1-28 of Cycles 1-8. Dexamethasone 40 mg by mouth on Days 1-4, 9-12, and 17-20 of Cycles 1-2, and 40 mg by mouth on Days 1, 8, 15, and 21 of Cycles 3-8.
Starting dose:15 mg daily by mouth on Days 1-21 followed by 7-day rest every 28 day cycle for Cycles 1-8
Other Names:Drug: Thalidomide
Starting dose:100 mg daily by mouth on Days 1-28 of Cycles 1-8
Other Name: ThalomidDrug: Dexamethasone
40 mg by mouth on Days 1-4, 9-12, and 17-20 of Cycles 1-2.
40 mg by mouth on Days 1, 8, 15, and 21 of Cycles 3-8.
Other Name: Decadron
- Maximum Tolerated Dose (MTD) of Combination of Lenalidomide, Thalidomide and Dexamethasone in Multiple Myeloma Participants [ Time Frame: End of Cycle 1 (28 Days) ]MTD of the combination of lenalidomide, thalidomide and dexamethasone in multiple myeloma subjects defined at the end of the trial, the dose with the smallest absolute value of (posterior mean of pi-pT) among all the tried doses i for which Ti=0 selected as the MTD.
- Overall Response of Combination of Lenalidomide, Thalidomide and Dexamethasone in Multiple Myeloma Participants [ Time Frame: End of 4 Cycles (112 Days) ]Overall response monitored using the Bayesian approach of Thall, Simon, Estey (1995, 1996) as extended by Thall and Sung (1998).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966693
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Donna M. Weber, MD, BS||M.D. Anderson Cancer Center|