Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma (AMM-2011)
This trial will determine the feasibility and efficacy of lenalidomide as maintenance therapy in Multiple Myeloma patients treated with dose intensive chemotherapy (Melphalan 200 mg/m2) with autologous PBSC transplant.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Autologous Peripheral Blood Stem Cell Transplantation and Maintenance Lenalidomide After High-dose Melphalan for Multiple Myeloma|
- Event Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Duration of time until patient experiences an event (recurrence, relapse or death)
- Disease Response [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Number of patients that have complete and very good partial responses.
- Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]Duration of time from Day 0 until death.
- Grade > 2 toxicities [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]Percent of patients experiencing one or more toxicity greater than 2.
- Incidence of infections [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]Percent of patients experiencing a definite or probable viral, fungal or bacterial infection.
- Treatment related Mortality [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]Number of patients that experience a death from causes other relapse or progression.
|Study Start Date:||April 2012|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
|Experimental: Maintenance Lenalidomide After Melphalan||
200 mg/m2/IVDrug: Lenalidomide
10 mg daily continuously for the first 3 months, then increased to 15 mg daily as long as the patient tolerates the drug.
|Contact: Hannah Spencer, MScfirstname.lastname@example.org|
|Contact: Amy Camblos, BSemail@example.com|
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Amy K Camblos, BS 434-982-3948 firstname.lastname@example.org|
|Principal Investigator: Mary J Laughlin, MD|
|Principal Investigator:||Mary J. Laughlin, MD||University of Virginia|