Melphalan, Prednisone, and Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00477750|
Recruitment Status : Completed
First Posted : May 24, 2007
Results First Posted : December 13, 2010
Last Update Posted : April 18, 2017
RATIONALE: Drugs used in chemotherapy, such as melphalan, prednisone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of melphalan and lenalidomide when given together with prednisone and to see how well they work in treating patients with newly diagnosed multiple myeloma.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: lenalidomide Drug: melphalan Drug: prednisone||Phase 1 Phase 2|
- Determine the maximum tolerated dose of melphalan and lenalidomide in combination with prednisone in patients with newly diagnosed multiple myeloma.
- Determine the response rate in patients treated with this regimen. Secondary
- Determine the toxicity of this regimen in these patients. OUTLINE: This is a dose-escalation study of melphalan and lenalidomide followed by a phase II study.
- Phase I: Patients receive oral melphalan and oral prednisone daily on days 1-4. Patients also receive oral lenalidomide daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of melphalan and lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
* Phase II: Patients receive oral melphalan and oral lenalidomide as in phase I at the MTD. Patients also receive oral prednisone as in phase I. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial of Melphalan, Prednisone Plus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Stem Cell Transplant|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||August 5, 2013|
U.S. FDA Resources
Experimental: Treatment (Lenalidomide, Melphalan, Prednisone)
Intervention: Drug: lenalidomide Dose determined by Phase I treatment schedule. Taken orally days 1-21 every 28 days until progression
Intervention: Drug: melphalan Dose determined by Phase I treatment schedule. Taken orally days 1-4 every 28 days until progression
Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression
Phase I - dose escalating: 5mg level -1, 10mg level 0, 10mg level 1, 15mg level 2, 20mg level 3, 25mg level 4, orally days 1-21 every 28 days until progression
Phase II - 10 mg orally days 1-21 every 28 days until progression
Phase I - dose escalating: 5mg/m^2 dose level -1, 5 mg/m^2 dose level 0, 8 mg/m^2 dose level 1 - 4, daily x 4 orally days every 28 days until progression
Phase II - 5mg/m^2 orally days 1-4 every 28 days until progression
60mg/m^2, orally days 1-4 every 28 days until progression
- Patients With Overall Confirmed Response [ Time Frame: Every cycle during treatment ]
Response that was confirmed on 2 consecutive evaluations.
- Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixations, normalization of Free Light Chain (FLC) ratio and <=5% plasma cells in bone marrow
- Very Good Partial Response (VGPR): >=90% reduction in serum M-spike, Urine M-spike <100mg per 24 hours
- Partial Response (PR): >=50% reduction in serum M-spike, Urine M-spike >=90% reduction or < 200mg per 24 hours, or >=50% decrease in difference between involved and uninvolved FLC levels or 50% decrease in bone marrow plasma cells
- Time to Progression (TTP) [ Time Frame: registration to progressive disease (up to 3 years) ]TTP was defined as the time from registration to disease progression. Patients who died were considered to have disease progression at time of death unless documented evidence clearly indicates no progression has occurred
- Overall Survival (OS) [ Time Frame: registration to death (up to 3 years) ]OS was defined as the time from registration to death due to any cause. Patients who were alive were censored at date of last follow-up.
- Duration of Response (DOR) [ Time Frame: from first response to progression or death (up to 3 years) ]Duration of response was calculated from documentation of first response to date of progression in the subset of patients who responded. Patients without progression were censored at the date of last tumor evaluation.
- Patients With Grade 3 or Higher Adverse Events [ Time Frame: Every cycle during treatment ]Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0.
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): NCT00477750
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259-5499|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Vivek Roy, MD, FACP||Mayo Clinic|
|Principal Investigator:||Philip R. Greipp, MD||Mayo Clinic|
|Principal Investigator:||Craig B. Reeder, MD||Mayo Clinic|