Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102)
A Trial of Tandem Autologous Stem Cell Transplants +/- Post Second Autologous Transplant Maintenance Therapy vs Single Autologous Stem Cell Transplant Followed by Matched Sibling Non-myeloablative Allogeneic Stem Cell Transplant for Patients With Multiple Myeloma (BMT CTN #0102)
4 other identifiers
interventional
710
1 country
36
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Dec 2003
Longer than P75 for phase_3 multiple-myeloma
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 9, 2004
CompletedFirst Posted
Study publicly available on registry
January 13, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
August 4, 2016
CompletedNovember 1, 2021
August 1, 2017
8.5 years
January 9, 2004
December 17, 2014
October 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
Patients are considered a failure for this endpoint if they die or if they progress or relapse.
Year 3
Secondary Outcomes (7)
Overall Survival (OS) for Standard Risk
Years 1, 2, and 3
Overall Survival (OS) for High Risk
Year 3
Cumulative Incidence of Progression/Relapse
Year 3
Cumulative Incidence of Treatment Related Mortality (TRM)
Year 3
Interval From First to Second Transplantation
Year 1
- +2 more secondary outcomes
Study Arms (3)
Auto transplants plus Therapy
ACTIVE COMPARATOROne autologous transplant along with a second autologous transplant will be preformed followed by one year of Dexamethasone and Thalidomide maintenance therapy.
Auto transplants
ACTIVE COMPARATOROne autologous transplant along with a second autologous transplant will be preformed followed by one year of observation.
Auto and Allo transplants
ACTIVE COMPARATOROne autologous transplant and one non-myeloablative allogeneic transplant will be preformed and followed by one year of observation.
Interventions
Melphalan will be administered at a dose of 200 mg/m2. Melphalan will be given in one dose infused on Day -2. Melphalan dose is based on ideal body weight (IBW) for patients who weigh 100-120% of their IBW. All patients will receive an autologous graft with a minimum cell dose of 2.0 x 106 CD34+ cells/kg patient weight. Patients will receive \~5 ug/kg/day of Granulocyte-Colony Stimulating Factor (G-CSF) subcutaneously from Day 5 post-transplant until absolute neutrophil count (ANC) \> 500/mm3 for two days.
Upon recovery and at least Day 60 post-autograft, patients with an available 6/6 HLA matched sibling will receive an allograft after non-myeloablative conditioning. Day 0 patients will receive Total Body Irradiation (TBI) 2.0 Gy from a linear accelerator ≤ 20 cGy/min, followed by allogeneic peripheral blood stem cell (PBSC) infusion. Commence cyclosporine (CSA) on Day -3 at 5 mg/kg bid PO for a daily dose of 10 mg/kg/day through Day +84 based on actual body weight. Starting on Day 84, patients in partial or complete response with the absence of graph versus host disease (GVHD) will have CSA tapered so the patient will be off CSA by Day 180. Oral administration of Mycophenolate Mofetil will be at a daily dose of 30 mg/kg/day from the evening of Day 0 until Day 27 post-transplant.
Upon recovery from the first autograft, but at least 60 days (preferably between 60-120 days) after the first autograft, patients without an HLA-matched sibling donor will receive a second autograft, also conditioned with melphalan 200 mg/m2.
Patients will be initiated on a starting dose of 50 mg/day. The dose will be increased weekly by 50 mg as tolerated to achieve a target dose of 200 mg/day. Patients will be treated for 12 months with thalidomide.
Patients will receive dexamethasone at a dose of 40 mg per day during Days 1-4 of each month for 12 months. The first dose of dexamethasone to be given the same day the patient starts thalidomide.
One year of observation post-transplants.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)lead
- Blood and Marrow Transplant Clinical Trials Networkcollaborator
- National Cancer Institute (NCI)collaborator
- National Marrow Donor Programcollaborator
Study Sites (36)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
City of Hope Samaritan
Phoenix, Arizona, 85006, United States
City of Hope National Medical Center
Duarte, California, 91010-3000, United States
Scripps Clinic/Green Hospital
La Jolla, California, 92037-1027, United States
UCSD Medical Center
La Jolla, California, 92093, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
University of Florida College of Medicine (Shands)
Gainesville, Florida, 32610-100277, United States
Emory University
Atlanta, Georgia, 30322, United States
BMT Group of Georgia/Northside Hospital
Atlanta, Georgia, 30342, United States
Loyola University
Maywood, Illinois, 60156, United States
IBMT (Indiana Blood and Marrow Transplant) at St Francis Franciscan Health
Indianapolis, Indiana, 46237, United States
Wichita CCOP
Wichita, Kansas, 67214, United States
Tufts - New England Medical Center
Boston, Massachusetts, 02111, United States
DFCI/Brigham & Women's
Boston, Massachusetts, 02114, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109-0942, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Jewish Hospital BMT Program
Cincinnati, Ohio, 45236, United States
University Hospitals of Cleveland/Case Western
Cleveland, Ohio, 44106, United States
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health Sciences University (A)
Portland, Oregon, 97239-3098, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Fox Chase - Temple University - BMT Program
Philadelphia, Pennsylvania, 19111-2442, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Baylor College of Medicine/The Methodist Hospital
Houston, Texas, 77030, United States
University of Texas/MD Anderson Cancer Research Center
Houston, Texas, 77030, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Utah BMT/Univ of Utah Med School
Salt Lake City, Utah, 84132, United States
Virginia Commonwealth University MCV Hospitals
Richmond, Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024, United States
University of Wisconsin Hospitals & Clinics
Madison, Wisconsin, 53792-6164, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (3)
Krishnan A, Pasquini MC, Logan B, Stadtmauer EA, Vesole DH, Alyea E 3rd, Antin JH, Comenzo R, Goodman S, Hari P, Laport G, Qazilbash MH, Rowley S, Sahebi F, Somlo G, Vogl DT, Weisdorf D, Ewell M, Wu J, Geller NL, Horowitz MM, Giralt S, Maloney DG; Blood Marrow Transplant Clinical Trials Network (BMT CTN). Autologous haemopoietic stem-cell transplantation followed by allogeneic or autologous haemopoietic stem-cell transplantation in patients with multiple myeloma (BMT CTN 0102): a phase 3 biological assignment trial. Lancet Oncol. 2011 Dec;12(13):1195-203. doi: 10.1016/S1470-2045(11)70243-1. Epub 2011 Sep 29.
PMID: 21962393RESULTLogan B, Leifer E, Bredeson C, Horowitz M, Ewell M, Carter S, Geller N. Use of biological assignment in hematopoietic stem cell transplantation clinical trials. Clin Trials. 2008;5(6):607-16. doi: 10.1177/1740774508098326.
PMID: 19029209RESULTGiralt S, Costa LJ, Maloney D, Krishnan A, Fei M, Antin JH, Brunstein C, Geller N, Goodman S, Hari P, Logan B, Lowsky R, Qazilbash MH, Sahebi F, Somlo G, Rowley S, Vogl DT, Vesole DH, Pasquini M, Stadtmauer E. Tandem Autologous-Autologous versus Autologous-Allogeneic Hematopoietic Stem Cell Transplant for Patients with Multiple Myeloma: Long-Term Follow-Up Results from the Blood and Marrow Transplant Clinical Trials Network 0102 Trial. Biol Blood Marrow Transplant. 2020 Apr;26(4):798-804. doi: 10.1016/j.bbmt.2019.11.018. Epub 2019 Nov 19.
PMID: 31756536DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Adam Mendizabal
- Organization
- The EMMES Corporation
Study Officials
- STUDY DIRECTOR
Mary Horowitz, MD
Center for International Blood and Marrow Transplant Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2004
First Posted
January 13, 2004
Study Start
December 1, 2003
Primary Completion
June 1, 2012
Study Completion
March 1, 2013
Last Updated
November 1, 2021
Results First Posted
August 4, 2016
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Within 6 months of official study closure at participating sites.
- Access Criteria
- Available to the public
Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).