Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)

Not Recruiting

Trial ID: NCT01109004

Purpose

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.

Official Title

A Trial of Single Autologous Transplant With or Without Consolidation Therapy Versus Tandem Autologous Transplant With Lenalidomide Maintenance for Patients With Multiple Myeloma (BMT CTN 0702)

Stanford Investigator(s)

Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Judith Shizuru
Judith Shizuru

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

Eligibility


Inclusion Criteria:

   - 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 alanine
   aminotransferase (ALT) and aspartate aminotransferase (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: Diffusing capacity of the lung for carbon monoxide (DLCO), forced
   expiratory volume in one second (FEV1), or forced vital capacity (FVC) greater 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.

Exclusion Criteria:

   - 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 deep vein thrombosis (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.

Intervention(s):

drug: Lenalidomide

drug: lenalidomide, bortezomib and dexamethasone

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ilia Tantsura
650-723-0501

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