Lenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant in Multiple Myeloma
This is a research study for newly diagnosed multiple myeloma or multiple myeloma has returned (relapsed). Multiple myeloma is a type of cancer that begins in white blood cells called plasma cells. Plasma cells make proteins that help fight infections. Current therapy for multiple myeloma includes high dose chemotherapy and autologous (patient's own cells) stem cell transplantation.
There will be two parts (or phases) to this study:
The purpose of the first part is to find the highest dose of a drug called lenalidomide (Revlimid®) that can be given in combination with high dose melphalan without causing severe adverse events.
The purpose of the second part is to find out the effects of this treatment (good and bad) on multiple myeloma patients.
|Multiple Myeloma||Drug: Lenalidomide plus Melphalan during autologous stem cell transplantation Drug: Lenalidomide maintenance||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Oral Lenalidomide and High Dose Melphalan Supported by Autologous Peripheral Blood Stem Cell Infusion for Patients With Multiple Myeloma|
- To determine the recommended phase II dosing and toxicity profile of lenalidomide when used in combination with high dose melphalan in the setting of autologous stem cell transplantation in patients with multiple myeloma [ Time Frame: 48 months ]
- To evaluate the response rate of the regimen [ Time Frame: 48 months ]
- To explore the biologic effect of the regimen. [ Time Frame: 48 months ]The biologic effect of the regimen will be measured using quantitative analysis of tumor load, extent of DNA damage, quantitative analysis of plasma cell by RT-PCR, characterization and quantification of circulating endothelial cells, and using Hevylite assay to correlate with serum monoclonal proteins and serum free kappa and lambda light chain assay.
|Actual Study Start Date:||August 27, 2010|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Melphalan with lenalidomide
Melphalan will be given on Day -2 and Day -1. Lenalidomide will be given from Day -7 to Day +2.
Drug: Lenalidomide plus Melphalan during autologous stem cell transplantation
Patients will receive a fixed dose of melphalan, while the dose of lenalidomide is escalated according to the protocol defined cohorts. Lenalidomide is given on day -7 to day +2, while intravenous melphalan is given on day -2 and -1. Lenalidomide dosing will be in the morning at approximately the same time each day.Drug: Lenalidomide maintenance
Lenalidomide maintenance therapy will begin on Day +100 to Day +110 provided the protocol-defined criteria are met. The initial starting dose of lenalidomide during maintenance is 10 mg daily on Days 1-28 of each 28-day cycle.
Lenalidomide is a drug that interferes with the development of tiny blood vessels that help tumors grow. Lenalidomide in combination with dexamethasone is approved by the Food and Drug Administration (FDA) for the treatment of relapsed multiple myeloma. It is also approved for the treatment of specific types of myelodysplastic syndrome (MDS), another blood cancer. Other research studies using lenalidomide in combination with other drugs in subjects with newly diagnosed multiple myeloma also show good response rate.
High dose melphalan is approved by the FDA and is commonly used in multiple myeloma treatment prior to stem cell transplantation. This combination of lenalidomide, high-dose melphalan and stem cell transplantation has not been studied in newly diagnosed and relapsed multiple myeloma, so it is considered experimental. In research studies, "experimental" refers to a drug or procedure that has undergone basic laboratory testing and received approval from the US Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered experimental in other diseases or conditions.
In this study, lenalidomide will be given together with melphalan (chemotherapy) with the hope that more disease will be killed before the stem cell transplant. Three months after the transplant, patients will take lenalidomide again with the hope that this will help prolong the time when the disease is in remission.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142232
|United States, Indiana|
|IU Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Attaya Suvannasankha, MD||Indiana University School of Medicine|