Clinical Trial VICCBMT1049
A Trial of Single Autologous Transplant with or without Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for Patients with Multiple Myeloma
- Protocol No. VICCBMT1049
- Open Date: 11/17/2011
- Staging: Phase III
- Age Group: Adults
- Scope: National
- Objective: The primary objective of the randomized trial is to compare PFS between the two single transplant arms and between each single transplant arm and the tandem transplant arm.
- Disease Sites: Multiple Myeloma
- Therapies: Bone Marrow/Stem Cell Transplant; Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Bortezomib (BTZ); Dexamethasone; Lenalidomide; Melphalan; VELCADE
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01109004
- Secondary Protocol No: 0702
This study will look at three different treatments for multiple myeloma. This study will compare the time it takes for the myeloma to become active between the three treatment groups. It will also compare how the disease responds to the treatment given to each patient, that is, how the cancer is acting one year after starting the study trial and each year after that. This study will also try to find out if one treatment extends patients- lives longer than the other treatments, what the side effects of each of the treatments are, the quality of life of participants, and how often patients get infections. The study may find that patients who have different treatments for multiple myeloma have similar results.
|Ages Eligible for Study:||N/A to 70 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• 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 1.5x the upper limit of normal and ALT and AST less than 2.5x the upper limit of normal. (Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value of 1.5x the upper limit of normal.)
• Renal: Creatinine clearance of grater than or equal to 40 mL/min, estimated or calculated.
• Pulmonary: DLCO, FEV1, FVC grater than 50 percent of predicted value (corrected for hemoglobin).
• 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 relevant.
• 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 greater than 5 years previously is allowed.
• 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 maintenance therapy.
• Prior allograft or prior autograft.
• Patients who have received mid-intensity melphalan (greater than 50 mg IV) as part of prior therapy.
• 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 a priori denial of medical costs coverage by third party payers.
• Patients unable to unwilling to return to the transplant center for their assigned treatments.