Status:
COMPLETED
Lenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant in Multiple Myeloma
Lead Sponsor:
Attaya Suvannasankha
Collaborating Sponsors:
Celgene
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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. Pl...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Phase I: Patients with diagnosis of multiple myeloma at any stage of disease undergoing high dose chemotherapy and stem cell transplantation.
- Phase II: Patients with myeloma undergoing a first high dose chemotherapy and stem cell transplantation after achieving at least stable disease following induction therapy. Any induction regimen prior to transplantation is allowed. No more than 2 prior lines of therapy prior to transplantation are allowed.
- All previous therapy not associated with peripheral blood stem cell transplant, including radiation, hormonal therapy, and surgery, must have been discontinued 4 weeks prior to treatment in this study.
- ECOG performance status of \</= 2 at study entry
- Laboratory test results within protocol-specified ranges
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®
- Females of childbearing potential must have negative pregnancy test within 24 hours of first prescription for lenalidomide and must commit to either continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control.
- Able to take aspirin daily as prophylactic anticoagulation
- Subject must have the minimum stem cell dose of 5.0 x 10\^6 CD34+ cells/kg collected.
Exclusion
- Pregnant or breast feeding females
- History of intolerance or resistance to lenalidomide
- Known hypersensitivity to thalidomide
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Known seropositive for or active viral infection with human immunodeficiency vrus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis b virus vaccine are eligible.
Key Trial Info
Start Date :
August 27 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01142232
Start Date
August 27 2010
End Date
May 18 2019
Last Update
October 22 2019
Active Locations (1)
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1
IU Simon Cancer Center
Indianapolis, Indiana, United States, 46202