Dose-finding of Lenalidomide as Maintenance in Multiple Myeloma
This study is a Phase I (non-randomized) study evaluating three dose-levels of Lenalidomide in patients after allogeneic stem cell transplantation, accomplished in two institutions (University Medical Center Hamburg-Eppendorf/ University Medical Center Heidelberg).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dose-finding Study of Lenalidomide as Maintenance Therapy in Multiple Myeloma After Allogeneic Stem Cell Transplantation|
- Maximal tolerable dose of lenalidomide after allogeneic stem cell transplantation in patients with multiple myeloma [ Time Frame: 2 years post-transplantation ] [ Designated as safety issue: Yes ]
- Determination of remission status after lenalidomide treatment [ Time Frame: 2 years post-transplantation ] [ Designated as safety issue: Yes ]
- Effect on T-cell/ NK-cell recovery [ Time Frame: 1 year post-transplantation ] [ Designated as safety issue: Yes ]
- Incidence of infectious complications and GvHD [ Time Frame: 1 year post-transplantation ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2009|
|Study Completion Date:||December 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Lenalidomide-treatment starts between 100 and 180 days after allogeneic stem cell transplantation. Three dose-levels will be investigated.
Drug: Revlimid (Lenalidomide)
3 pat. will be enrolled on dose level 0. If no DLTs are observed during cycles 1+2 dose will be escalated to the next higher level in the 3 patients. If 1 of 3 pat. experiences DLT at the current dose, then up to 3 more pat. will be accrued at the same level. If none of these 3 additional pat. experience DLT dose will be escalated in subsequent patients. If 1 of these 3 patients experiences DLT, the next lower level will be declared to be MTD and the study will be filled up with patients at this dose level up to 25 pat. overall.
If 2 or more of 3 pat. or 3 or more of 6 pat. in the same cohort encounter DLT, the MTD has been exceeded and the previous lower dose level will be declared as MTD and the study will be filled up with patients at this level up to 25 pat. overall.
If DLT is observed in level 0, the next dose level will be -1 for the following cohort of 3 patients. If level 2 is well tolerated without DLT, this level will be claimed as recommended dose for further trials.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778752
|Hamburg, Germany, 20246|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Nicolaus Kroeger, Prof. Dr.||University Medical Center Hamburg-Eppendorf, Germany|