Lenalidomide and High-Dose Melphalan
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|ClinicalTrials.gov Identifier: NCT01079936|
Recruitment Status : Completed
First Posted : March 3, 2010
Results First Posted : June 6, 2016
Last Update Posted : June 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Myeloma Stem Cell Transplantation||Drug: Lenalidomide Drug: Melphalan Procedure: Stem Cell Infusion||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study Of The Combination Of Lenalidomide With High-Dose Melphalan For Autologous Transplant in Patients With Multiple Myeloma|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Experimental: Lenalidomide + High-Dose Melphalan
Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
Beginning dose level 25 mg by mouth (PO) on Days -8 to -2
Dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion
Other Name: Alkeran
Procedure: Stem Cell Infusion
Stem cell infusion on Day 0.
- Maximum Tolerated Dose (MTD) of Lenalidomide [ Time Frame: Assessed at 21-28 Day Cycle ]There were 4 doses of lenalidomide in the dose escalation phase: 25 mg, 50 mg, 75 mg, and 100 mg. The first 12 patients were treated at these dose levels (3 patients per level) and safety assessed at each level. The MTD dose level was to be the level at which participants at each lenalidomide dose level had no dose limiting toxicity (DLT). DLT defined as as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT. Each participant received a fixed dose of Melphalan plus one of the four doses 25, 50, 75 or 100 mg of Lenalidomide orally for each of 7 days, -8 to -2 pre transplant.
- Number of Participants With Response (CR at Day 90) [ Time Frame: Day 90 after stem cell transplant ]Response is defined as the event that the participant is alive with complete response (CR) at day 90 (+/-30 days). CR defined as: A) Absence of monoclonal protein in urine and serum when analyzed by immunofixation electrophoresis. B) The bone marrow should be normal by morphological examination with <5% plasma cells. There should be < 1% aneuploid light chain restricted population by flow cytometry for DNA/cIg. C) While healing of bone lesions not required, no new lytic lesion should appear. Further compression fracture of spine will be not considered as progressive disease.
- Number of Participants With Day 30 DLT (Overall Study, Phase I/Phase II) [ Time Frame: Day 30 following transplant ]Dose limiting toxicity (DLT) was defined as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT.
- Participants With Grade 3 =/> Adverse Events [ Time Frame: Day 90 after stem cell transplant ]Number of participants experiencing adverse events above a Grade 3 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.
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): NCT01079936
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Muzaffar H. Qazilbash, MD||UT MD Anderson Cancer Center|