Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)
Phase: Phase 3
Diagnosis: Multiple Myeloma
NCT ID: NCT01109004
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-136
The study is designed as a Phase III, multicenter trial of tandem autologous transplants plus maintenance therapy versus the strategy of single autologous transplant plus consolidation therapy with lenalidomide, bortezomib and dexamethasone (RVD) followed by maintenance therapy or single autologous transplant plus maintenance therapy as part of upfront treatment of multiple myeloma (MM). Lenalidomide will be used as maintenance therapy for three years in all arms.
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital
John Koreth, MD,
Dana-Farber Cancer Institute
Anuj Mahindra, M.D.,
Massachusetts General Hospital
Dana-Farber Cancer Institute:
Muriel Gannon, 617-632-4597,
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
- Patients meeting the criteria for symptomatic multiple myeloma (MM).
- Patients who are 70 years of age, or younger, at time of enrollment.
- Patients who have received at least two cycles of any regimen as initial systemic
therapy and are within 2 - 12 months of the first dose of initial therapy.
- Cardiac function: left ventricular ejection fraction at rest greater than 40 percent.
- Hepatic: bilirubin less than 2 times the upper limit of normal and ALT and AST less
than 2.5 times the upper limit of normal.
- Renal: Creatinine clearance of grater than or equal to 40 mL/min, estimated or
- Pulmonary: DLCO, FEV1, FVC grater than 50 percent of predicted value (corrected for
- Patients with an adequate autologous graft defined as a cryopreserved PBSC graft
containing greater than or equal to 4 x 10^6 CD34+ cells/kg patient weight. The graft
may not be CD34+ selected or otherwise manipulated to remove tumor or other cells.
The graft can be collected at the transplanting institution or by a referring center.
The autograft must be stored so that there are two products each containing at least
2 x 10^6 CD34+ cells/kg patient weight.
- Signed informed consent form.
- Patients who never fulfill the criteria for symptomatic MM.
- Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in
serum as measured by electrophoresis and immunofixation and the absence of Bence
Jones protein in the urine defined by use of conventional electrophoresis and
immunofixation techniques]. Patients with light chain MM detected in the serum by
free light chain assay are eligible.
- Patients with plasma cell leukemia.
- Karnofsky performance score less than 70 percent.
- Patients with greater than grade 2 sensory neuropathy (CTCAE).
- Patients with uncontrolled bacterial, viral or fungal infections (currently taking
medication and progression of clinical symptoms).
- Patients seropositive for the human immunodeficiency virus (HIV).
- Myocardial infarction within 6 months prior to enrollment or has New York Heart
Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
ischemia or active conduction system abnormalities. Prior to study entry, any ECG
abnormality at Screening has to be documented by the investigator as not medically
- Patient has hypersensitivity to bortezomib, boron or mannitol.
- Patient has received other investigational drugs with 14 days before enrollment.
- Patients with prior malignancies except resected basal cell carcinoma or treated
cervical carcinoma in situ. Cancer treated with curative intent less than 5 years
previously will not be allowed unless approved by the Protocol Officer or one of the
Protocol Chairs. Cancer treated with curative intent >5 years previously are
- Female patients who are pregnant (positive B-HCG) or breastfeeding.
- Females of childbearing potential (FCBP) or men who have sexual contact with FCBP
unwilling to use contraceptive techniques during the length of lenalidomide
- Prior allograft or prior autograft.
- Patients who have received mid-intensity melphalan (greater than 50 mg IV) as part of
- Patients unable or unwilling to provide informed consent.
- Prior organ transplant requiring immunosuppressive therapy.
- Patients with disease progression prior to enrollment.
- Patients who have received lenalidomide as initial therapy for MM and have
experienced toxicities resulting in treatment discontinuation.
- Patients who experienced thromboembolic events while on full anticoagulation during
prior therapy with lenalidomide or thalidomide.
- Patients unwilling to take DVT prophylaxis.
- Patients who cannot undergo an intervention in any treatment arm due to apriori
denial of medical costs coverage by third party payers.
- Patients unable to unwilling to return to the transplant center for their assigned