Dose-finding of Lenalidomide as Maintenance in Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00778752|
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : May 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Revlimid (Lenalidomide)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dose-finding Study of Lenalidomide as Maintenance Therapy in Multiple Myeloma After Allogeneic Stem Cell Transplantation|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||December 2013|
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.
- Maximal tolerable dose of lenalidomide after allogeneic stem cell transplantation in patients with multiple myeloma [ Time Frame: 2 years post-transplantation ]
- Determination of remission status after lenalidomide treatment [ Time Frame: 2 years post-transplantation ]
- Effect on T-cell/ NK-cell recovery [ Time Frame: 1 year post-transplantation ]
- Incidence of infectious complications and GvHD [ Time Frame: 1 year post-transplantation ]
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): NCT00778752
|Hamburg, Germany, 20246|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Nicolaus Kroeger, Prof. Dr.||University Medical Center Hamburg-Eppendorf, Germany|