Multiple MyelomaPhase 3NCT00075829
Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102)
A Phase 3 study testing One Autologous Transplant, Non-Myeloablative Allogeneic Transplant and Second Autologous Transplant in people with Multiple Myeloma, run by National Heart, Lung, and Blood Institute (NHLBI) at 36 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- One Autologous Transplant, Non-Myeloablative Allogeneic Transplant and Second Autologous Transplant
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- 36 sitesUnited States
- Study dates
- Dec 2003to Mar 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109-0942
Emory University
Atlanta, Georgia, 30322
BMT Group of Georgia/Northside Hospital
Atlanta, Georgia, 30342
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Tufts - New England Medical Center
Boston, Massachusetts, 02111
DFCI/Brigham & Women's
Boston, Massachusetts, 02114
Jewish Hospital BMT Program
Cincinnati, Ohio, 45236
University Hospitals of Cleveland/Case Western
Cleveland, Ohio, 44106
Colorado Blood Cancer Institute
Denver, Colorado, 80218
City of Hope National Medical Center
Duarte, California, 91010-3000
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida College of Medicine (Shands)
Gainesville, Florida, 32610-100277
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Baylor College of Medicine/The Methodist Hospital
Houston, Texas, 77030
University of Texas/MD Anderson Cancer Research Center
Houston, Texas, 77030
IBMT (Indiana Blood and Marrow Transplant) at St Francis Franciscan Health
Indianapolis, Indiana, 46237
Scripps Clinic/Green Hospital
La Jolla, California, 92037-1027
UCSD Medical Center
La Jolla, California, 92093
University of Wisconsin Hospitals & Clinics
Madison, Wisconsin, 53792-6164
Loyola University
Maywood, Illinois, 60156
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University
Nashville, Tennessee, 37232
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Fox Chase - Temple University - BMT Program
Philadelphia, Pennsylvania, 19111-2442
City of Hope Samaritan
Phoenix, Arizona, 85006
Oregon Health Sciences University (A)
Portland, Oregon, 97239-3098
Virginia Commonwealth University MCV Hospitals
Richmond, Virginia, 23298
Utah BMT/Univ of Utah Med School
Salt Lake City, Utah, 84132
Texas Transplant Institute
San Antonio, Texas, 78229
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Stanford Hospital and Clinics
Stanford, California, 94305
Wichita CCOP
Wichita, Kansas, 67214
About this study
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)
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- One Autologous Transplant, Non-Myeloablative Allogeneic Transplant, Second Autologous Transplant, Thalidomide, Dexamethasone
- Keywords
- Stage II Multiple Myeloma, Stage III Multiple Myeloma, Refractory Plasma Cell Neoplasm
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Autologous TransplantProcedure or surgery
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.
Non-Myeloablative Allogeneic TransplantProcedure or surgery
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.
Second Autologous TransplantProcedure or surgery
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.
ThalidomideDrug
Also called Thalomid™
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.
DexamethasoneDrug
Also called Decadron, DexPak
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.
ObservationBehavioural
One year of observation post-transplants.
| Study group | Role | What they receive |
|---|---|---|
| Auto transplants plus Therapy | Active comparator | One autologous transplant along with a second autologous transplant will be preformed followed by one year of Dexamethasone and Thalidomide maintenance therapy. Receives: Procedure: One Autologous Transplant; Procedure: Second Autologous Transplant; Drug: Thalidomide; Drug: Dexamethasone |
| Auto transplants | Active comparator | One autologous transplant along with a second autologous transplant will be preformed followed by one year of observation. Receives: Procedure: One Autologous Transplant; Procedure: Second Autologous Transplant; Behavioral: Observation |
| Auto and Allo transplants | Active comparator | One autologous transplant and one non-myeloablative allogeneic transplant will be preformed and followed by one year of observation. Receives: Procedure: One Autologous Transplant; Procedure: Non-Myeloablative Allogeneic Transplant; Behavioral: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Patients are considered a failure for this endpoint if they die or if they progress or relapse.
Measured: Year 3
Secondary outcomes (7)
Overall Survival (OS) for Standard Risk
The event is death from any cause, patients alive at the time of last observation are considered censored.
Measured: Years 1, 2, and 3
Overall Survival (OS) for High Risk
The event is death from any cause, patients alive at the time of last observation are considered censored.
Measured: Year 3
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.
Measured: Year 3
Cumulative Incidence of Treatment Related Mortality (TRM)
TRM is defined as death occurring in a patient from causes other than relapse or progression.
Measured: Year 3
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.
Measured: Year 1
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.
Measured: Day 100
Incidences of Chronic GVHD
Incidence and severity of chronic GVHD will be scored according to the BMT clinical trials network Manual of Procedures.
Measured: Years 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2004 (estimated)
- Study startDec 2003
- Primary completionJun 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 710 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program
- Responsible party
- Sponsor
- Investigators
- Mary Horowitz, MD, Study director, Center for International Blood and Marrow Transplant Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075829
- Sponsor's protocol ID
- BMTCTN0102
- Other IDs
- BMT CTN 0102, SUMC-79730, 417
- Status last verified
- Aug 2017
- First submitted
- 9 Jan 2004
- Last updated
- 1 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 21962393Logan 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.
PubMed 19029209Giralt 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.
PubMed 31756536
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00075829
- Acronym / sponsor ID
- BMTCTN0102
- Conditions
- Multiple Myeloma
- Keywords
- Stage II Multiple Myeloma, Stage III Multiple Myeloma, Refractory Plasma Cell Neoplasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 710 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program
- Study start
- Dec 2003
- Primary completion
- Jun 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Jan 2004 (estimated)
- Results
- Posted 4 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Auto transplants plus Therapy | Active comparator | Procedure: One Autologous Transplant, Procedure: Second Autologous Transplant, Drug: Thalidomide, Drug: DexamethasoneOne autologous transplant along with a second autologous transplant will be preformed followed by one year of Dexamethasone and Thalidomide maintenance therapy. |
| Auto transplants | Active comparator | Procedure: One Autologous Transplant, Procedure: Second Autologous Transplant, Behavioral: ObservationOne autologous transplant along with a second autologous transplant will be preformed followed by one year of observation. |
| Auto and Allo transplants | Active comparator | Procedure: One Autologous Transplant, Procedure: Non-Myeloablative Allogeneic Transplant, Behavioral: ObservationOne autologous transplant and one non-myeloablative allogeneic transplant will be preformed and followed by one year of observation. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One Autologous TransplantMelphalan 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. | Procedure or surgery | Auto and Allo transplants, Auto transplants, Auto transplants plus Therapy |
| Non-Myeloablative Allogeneic TransplantUpon 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. | Procedure or surgery | Auto and Allo transplants |
| Second Autologous TransplantUpon 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. | Procedure or surgery | Auto transplants, Auto transplants plus Therapy |
| ThalidomideAlso: Thalomid™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. | Drug | Auto transplants plus Therapy |
| DexamethasoneAlso: Decadron, DexPakPatients 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. | Drug | Auto transplants plus Therapy |
| ObservationOne year of observation post-transplants. | Behavioural | Auto and Allo transplants, Auto transplants |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Year 3
Patients are considered a failure for this endpoint if they die or if they progress or relapse.
7 secondary outcomes
Overall Survival (OS) for Standard Risk
Time frame: Years 1, 2, and 3
Overall Survival (OS) for High Risk
Time frame: Year 3
Cumulative Incidence of Progression/Relapse
Time frame: Year 3
Cumulative Incidence of Treatment Related Mortality (TRM)
Time frame: Year 3
Interval From First to Second Transplantation
Time frame: Year 1
Incidences of Graft Versus Host Disease (GVHD)
Time frame: Day 100
Incidences of Chronic GVHD
Time frame: Years 1 and 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21962393Krishnan 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 publication: PubMed 19029209Logan 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.
- Derived from this study: PubMed 31756536Giralt 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Horowitz, MD study director
Center for International Blood and Marrow Transplant Research
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing One Autologous Transplant, Non-Myeloablative Allogeneic Transplant and Second Autologous Transplant in people with Multiple Myeloma, run by National Heart, Lung, and Blood Institute (NHLBI) at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Year 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00075829, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.