Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma (AMM-2011)
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|ClinicalTrials.gov Identifier: NCT01617213|
Recruitment Status : Terminated (Study is no longer needed as recent data have answered the primary hypotheses for this study.)
First Posted : June 12, 2012
Last Update Posted : June 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Melphalan Drug: Lenalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Peripheral Blood Stem Cell Transplantation and Maintenance Lenalidomide After High-dose Melphalan for Multiple Myeloma|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||April 2015|
|Experimental: Maintenance Lenalidomide After Melphalan||
10 mg daily continuously for the first 3 months, then increased to 15 mg daily as long as the patient tolerates the drug.
- Event Free Survival [ Time Frame: 3 years ]Duration of time until patient experiences an event (recurrence, relapse or death)
- Disease Response [ Time Frame: 2 years ]Number of patients that have complete and very good partial responses.
- Overall survival [ Time Frame: 4 years ]Duration of time from Day 0 until death.
- Grade > 2 toxicities [ Time Frame: 4 years ]Percent of patients experiencing one or more toxicity greater than 2.
- Incidence of infections [ Time Frame: 4 years ]Percent of patients experiencing a definite or probable viral, fungal or bacterial infection.
- Treatment related Mortality [ Time Frame: 4 years ]Number of patients that experience a death from causes other relapse or progression.
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): NCT01617213
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Mary J. Laughlin, MD||University of Virginia|