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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
One Autologous Transplant
Non-Myeloablative Allogeneic Transplant
Second Autologous Transplant
Thalidomide
Dexamethasone
Observation
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Stage II Multiple Myeloma, Stage III Multiple Myeloma, Refractory Plasma Cell Neoplasm

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • University of Alabama at Birmingham
  • City of Hope Samaritan
  • City of Hope National Medical Center
  • Scripps Clinic/Green Hospital
  • UCSD Medical Center
  • Stanford Hospital and Clinics
  • Colorado Blood Cancer Institute
  • University of Florida College of Medicine (Shands)
  • Emory University
  • BMT Group of Georgia/Northside Hospital
  • Loyola University
  • IBMT (Indiana Blood and Marrow Transplant) at St Francis Franciscan Health
  • Wichita CCOP
  • Tufts - New England Medical Center
  • DFCI/Brigham & Women's
  • University of Michigan Medical Center
  • University of Minnesota
  • University of Nebraska Medical Center
  • Hackensack University Medical Center
  • Memorial Sloan-Kettering Cancer Center
  • Duke University Medical Center
  • Jewish Hospital BMT Program
  • University Hospitals of Cleveland/Case Western
  • University of Oklahoma Medical Center
  • Oregon Health Sciences University (A)
  • University of Pennsylvania Cancer Center
  • Fox Chase - Temple University - BMT Program
  • Vanderbilt University
  • Baylor College of Medicine/The Methodist Hospital
  • University of Texas/MD Anderson Cancer Research Center
  • Texas Transplant Institute
  • Utah BMT/Univ of Utah Med School
  • Virginia Commonwealth University MCV Hospitals
  • Fred Hutchinson Cancer Research Center
  • University of Wisconsin Hospitals & Clinics
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Auto transplants plus Therapy

Auto transplants

Auto and Allo transplants

Arm Description

One autologous transplant along with a second autologous transplant will be preformed followed by one year of Dexamethasone and Thalidomide maintenance therapy.

One autologous transplant along with a second autologous transplant will be preformed followed by one year of observation.

One autologous transplant and one non-myeloablative allogeneic transplant will be preformed and followed by one year of observation.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
Patients are considered a failure for this endpoint if they die or if they progress or relapse.

Secondary Outcome Measures

Overall Survival (OS) for Standard Risk
The event is death from any cause, patients alive at the time of last observation are considered censored.
Overall Survival (OS) for High Risk
The event is death from any cause, patients alive at the time of last observation are considered censored.
Cumulative Incidence of Progression/Relapse
Patients are considered experiencing an event when they progress. Deaths without progression are considered as a competing risk. Patients initiating non-protocol anti-myeloma therapy are considered to have progressed on this protocol.
Cumulative Incidence of Treatment Related Mortality (TRM)
TRM is defined as death occurring in a patient from causes other than relapse or progression.
Interval From First to Second Transplantation
Upon recovery from the first autograft, but at least 60 days (preferably between 60-120 days) after the first autograft, patients will receive a second transplant according to treatment assignments.
Incidences of Graft Versus Host Disease (GVHD)
Incidence and severity of GVHD will be scored according to the BMT clinical trials network Manual of Procedures.
Incidences of Chronic GVHD
Incidence and severity of chronic GVHD will be scored according to the BMT clinical trials network Manual of Procedures.

Full Information

First Posted
January 9, 2004
Last Updated
October 19, 2021
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program
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1. Study Identification

Unique Protocol Identification Number
NCT00075829
Brief Title
Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Multiple myeloma (MM), characterized by malignant plasma cell proliferation, bone destruction, and immunodeficiency, is a disease with a median age at diagnosis of approximately 65 years. It is responsible for about 1 percent of all cancer-related deaths in Western Countries. Conventional treatments with chemotherapy and radiation therapy are non-curative but improve quality of life and duration of survival. Attempts to cure myeloma through high-dose therapy followed by autografting or allografting have largely failed due to a combination of relapsed disease or transplant related mortality (TRM). High-dose therapy with autologous transplantation is safe and has low TRM (less than 5%), but is associated with a continuing and nearly universal risk of disease progression and relapse. Even so, autologous transplantation is superior to continued conventional chemotherapy. Recent data indicate that tandem autologous transplants are superior to a single procedure. Even with this approach, patients remain at risk of relapse and additional approaches are needed. DESIGN NARRATIVE: The overall study design is that of biologic assignment, based on the availability of an HLA-matched sibling, to one of two treatment strategies for MM patients. Patients without an HLA-matched sibling will undergo tandem autologous transplants. Patients with an HLA-matched sibling will undergo an autologous transplant followed by a non-myeloablative allogeneic transplant. In addition, the tandem autologous transplant recipients will be randomized to either observation or one year of maintenance therapy to begin following the second autologous transplant. The large number of MM patients without an HLA-matched sibling enables us to evaluate the role of maintenance therapy following tandem autologous transplants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Stage II Multiple Myeloma, Stage III Multiple Myeloma, Refractory Plasma Cell Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
710 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auto transplants plus Therapy
Arm Type
Active Comparator
Arm Description
One autologous transplant along with a second autologous transplant will be preformed followed by one year of Dexamethasone and Thalidomide maintenance therapy.
Arm Title
Auto transplants
Arm Type
Active Comparator
Arm Description
One autologous transplant along with a second autologous transplant will be preformed followed by one year of observation.
Arm Title
Auto and Allo transplants
Arm Type
Active Comparator
Arm Description
One autologous transplant and one non-myeloablative allogeneic transplant will be preformed and followed by one year of observation.
Intervention Type
Procedure
Intervention Name(s)
One Autologous Transplant
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non-Myeloablative Allogeneic Transplant
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Second Autologous Transplant
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Other Intervention Name(s)
Thalomid™
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron, DexPak
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Observation
Intervention Description
One year of observation post-transplants.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
Patients are considered a failure for this endpoint if they die or if they progress or relapse.
Time Frame
Year 3
Secondary Outcome Measure Information:
Title
Overall Survival (OS) for Standard Risk
Description
The event is death from any cause, patients alive at the time of last observation are considered censored.
Time Frame
Years 1, 2, and 3
Title
Overall Survival (OS) for High Risk
Description
The event is death from any cause, patients alive at the time of last observation are considered censored.
Time Frame
Year 3
Title
Cumulative Incidence of Progression/Relapse
Description
Patients are considered experiencing an event when they progress. Deaths without progression are considered as a competing risk. Patients initiating non-protocol anti-myeloma therapy are considered to have progressed on this protocol.
Time Frame
Year 3
Title
Cumulative Incidence of Treatment Related Mortality (TRM)
Description
TRM is defined as death occurring in a patient from causes other than relapse or progression.
Time Frame
Year 3
Title
Interval From First to Second Transplantation
Description
Upon recovery from the first autograft, but at least 60 days (preferably between 60-120 days) after the first autograft, patients will receive a second transplant according to treatment assignments.
Time Frame
Year 1
Title
Incidences of Graft Versus Host Disease (GVHD)
Description
Incidence and severity of GVHD will be scored according to the BMT clinical trials network Manual of Procedures.
Time Frame
Day 100
Title
Incidences of Chronic GVHD
Description
Incidence and severity of chronic GVHD will be scored according to the BMT clinical trials network Manual of Procedures.
Time Frame
Years 1 and 2

10. Eligibility

Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Horowitz, MD
Organizational Affiliation
Center for International Blood and Marrow Transplant Research
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
City of Hope Samaritan
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Scripps Clinic/Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-1027
Country
United States
Facility Name
UCSD Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
University of Florida College of Medicine (Shands)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-100277
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
BMT Group of Georgia/Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Loyola University
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60156
Country
United States
Facility Name
IBMT (Indiana Blood and Marrow Transplant) at St Francis Franciscan Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Wichita CCOP
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
DFCI/Brigham & Women's
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Jewish Hospital BMT Program
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
University Hospitals of Cleveland/Case Western
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Oklahoma Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health Sciences University (A)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase - Temple University - BMT Program
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2442
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor College of Medicine/The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas/MD Anderson Cancer Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Transplant Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Utah BMT/Univ of Utah Med School
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Virginia Commonwealth University MCV Hospitals
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
University of Wisconsin Hospitals & Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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).
IPD Sharing Time Frame
Within 6 months of official study closure at participating sites.
IPD Sharing Access Criteria
Available to the public
IPD Sharing URL
https://biolincc.nhlbi.nih.gov/home/
Citations:
PubMed Identifier
21962393
Citation
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.
Results Reference
result
PubMed Identifier
19029209
Citation
Logan 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.
Results Reference
result
PubMed Identifier
31756536
Citation
Giralt 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.
Results Reference
derived
Links:
URL
https://web.emmes.com/study/bmt2/index.html
Description
Blood and Marrow Transplant Clinical Trials Network Website
URL
https://bethematch.org/
Description
National Marrow Donor Program
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/bmtctn0102/
Available IPD/Information Identifier
BMT CTN-0102
Available IPD/Information Comments
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local Institutional Review Board (IRB) approval or certification of exemption from IRB review, and completion of a data use agreement.
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/bmtctn0102/
Available IPD/Information Identifier
BMT CTN-0102
Available IPD/Information Type
Study Forms
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/bmtctn0102/
Available IPD/Information Identifier
BMT CTN-0102

Learn more about this trial

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

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