Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102)

Completed · Phase 3

Conditions studied: Multiple Myeloma

In brief

The study is designed as a Phase III, multi-center trial of tandem autologous transplants versus the strategy of autologous followed by Human Leukocyte Antigen (HLA)-matched sibling non-myeloablative allogeneic transplant. Study subjects will be biologically assigned to the appropriate arm depending on the availability of an HLA-matched sibling. There is a nested randomized phase III trial of observation versus maintenance therapy following the second autologous transplant for patients on the tandem autologous transplant arm.

Key facts

Study ID: NCT00075829
Run by: National Heart, Lung, and Blood Institute (NHLBI)
People needed: 710
Starts: 2003-12-01
Expected to finish: 2013-03-01
Last updated by the study team: 2021-11-01

Who can join

Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Meeting the Durie and Salmon criteria for initial diagnosis of MM
Stage II or III MM at diagnosis or anytime thereafter
Symptomatic MM requiring treatment at diagnosis or anytime thereafter
Received at least three cycles of initial systemic therapy and are within 2-10 months of initiation of the initial therapy (this time frame excludes the time for mobilization therapy)
If receiving chemotherapy-based mobilization regimens, must be able to receive high-dose melphalan between 2 and 8 weeks after the initiation of mobilization therapy whether delivered at the transplant center or at a referring center
Adequate organ function as measured by:
Cardiac: Left ventricular ejection fraction at rest greater than 40%
Hepatic: Bilirubin less than 2 times the upper limit of normal and alanine transaminase (ALT) and aspartate transaminase (AST) less than 3 times the upper limit of normal
Renal: Creatinine clearance greater than 40 ml/min (measured or calculated/estimated)
Pulmonary: Carbon monoxide diffusion (DLCO), Volume forcibly exhaled in one second (FEV1), and Forced Vital Capacity (FVC) greater than 50% of predicted value (corrected for hemoglobin), or O2 saturation greater than 92% of room air
An adequate autologous graft defined as a cryopreserved PBSC graft containing at least 4.0 x 106 CD34+ cells/kg patient weight; if prior to enrollment it is known that a patient will be on the auto-allo arm (i.e., a consenting, eligible HLA-matched sibling donor is available), the required autograft must contain at least 2.0 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; for patients without an HLA-matched sibling donor, the autograft must be stored so that there are two products each containing at least 2 x 10\^6 CD34+ cells/kg patient weight

You may not qualify if…

Never advanced beyond Stage I MM since diagnosis
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)
Plasma cell leukemia
Karnofsky performance score less than 70%, unless approved by the Medical Monitor or one of the Protocol Chairs
Uncontrolled hypertension
Uncontrolled bacterial, viral, or fungal infections (currently taking medication and progression of clinical symptoms)
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 Medical Monitor or one of the Protocol Chairs; cancer treated with curative intent more than 5 years previously will be allowed
Pregnant or breastfeeding
Seropositive for the human immunodeficiency virus (HIV)
Unwilling to use contraceptive techniques during and for 12 months following treatment
Prior allograft or prior autograft
Received mid-intensity melphalan (more than 50 mg IV) as part of prior therapy
Prior organ transplant requiring immunosuppressive therapy

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
City of Hope Samaritan — Phoenix, Arizona, United States
City of Hope National Medical Center — Duarte, California, United States
Scripps Clinic/Green Hospital — La Jolla, California, United States
UCSD Medical Center — La Jolla, California, United States
Stanford Hospital and Clinics — Stanford, California, United States
Colorado Blood Cancer Institute — Denver, Colorado, United States
University of Florida College of Medicine (Shands) — Gainesville, Florida, United States
Emory University — Atlanta, Georgia, United States
BMT Group of Georgia/Northside Hospital — Atlanta, Georgia, United States
Loyola University — Maywood, Illinois, United States
IBMT (Indiana Blood and Marrow Transplant) at St Francis Franciscan Health — Indianapolis, Indiana, United States
Wichita CCOP — Wichita, Kansas, United States
Tufts - New England Medical Center — Boston, Massachusetts, United States
DFCI/Brigham & Women's — Boston, Massachusetts, United States
University of Michigan Medical Center — Ann Arbor, Michigan, United States
University of Minnesota — Minneapolis, Minnesota, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Duke University Medical Center — Durham, North Carolina, United States
Jewish Hospital BMT Program — Cincinnati, Ohio, United States
University Hospitals of Cleveland/Case Western — Cleveland, Ohio, United States
University of Oklahoma Medical Center — Oklahoma City, Oklahoma, United States
Oregon Health Sciences University (A) — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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