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NCT00075829 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2021-11-01

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-Free Survival (PFS)

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outcome · POSTED

Overall Survival (OS) for Standard Risk

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outcome · POSTED

Overall Survival (OS) for High Risk

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outcome · POSTED

Cumulative Incidence of Progression/Relapse

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outcome · POSTED

Cumulative Incidence of Treatment Related Mortality (TRM)

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outcome · POSTED

Interval From First to Second Transplantation

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outcome · POSTED

Incidences of Graft Versus Host Disease (GVHD)

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outcome · POSTED

Incidences of Chronic GVHD

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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: 1. Cardiac: Left ventricular ejection fraction at rest greater than 40% 2. 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 3. Renal: Creatinine clearance greater than 40 ml/min (measured or calculated/estimated) 4. 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
healthy Volunteers
false
maximum Age
70 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    One autologous transplant along with a second autologous transplant will be preformed followed by one year of Dexamethasone and Thalidomide maintenance therapy.
    intervention Names
    1. Procedure: One Autologous Transplant
    2. Procedure: Second Autologous Transplant
    3. Drug: Thalidomide
    4. Drug: Dexamethasone
    label
    Auto transplants plus Therapy
    type
    ACTIVE_COMPARATOR
  2. description
    One autologous transplant along with a second autologous transplant will be preformed followed by one year of observation.
    intervention Names
    1. Procedure: One Autologous Transplant
    2. Procedure: Second Autologous Transplant
    3. Behavioral: Observation
    label
    Auto transplants
    type
    ACTIVE_COMPARATOR
  3. description
    One autologous transplant and one non-myeloablative allogeneic transplant will be preformed and followed by one year of observation.
    intervention Names
    1. Procedure: One Autologous Transplant
    2. Procedure: Non-Myeloablative Allogeneic Transplant
    3. Behavioral: Observation
    label
    Auto and Allo transplants
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Auto and Allo transplants
    2. Auto transplants
    3. Auto transplants plus Therapy
    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.
    name
    One Autologous Transplant
    type
    PROCEDURE
  2. arm Group Labels
    1. Auto and Allo transplants
    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.
    name
    Non-Myeloablative Allogeneic Transplant
    type
    PROCEDURE
  3. arm Group Labels
    1. Auto transplants
    2. Auto transplants plus Therapy
    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.
    name
    Second Autologous Transplant
    type
    PROCEDURE
  4. arm Group Labels
    1. Auto transplants plus Therapy
    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.
    name
    Thalidomide
    other Names
    1. Thalomid™
    type
    DRUG
  5. arm Group Labels
    1. Auto transplants plus Therapy
    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.
    name
    Dexamethasone
    other Names
    1. Decadron, DexPak
    type
    DRUG
  6. arm Group Labels
    1. Auto and Allo transplants
    2. Auto transplants
    description
    One year of observation post-transplants.
    name
    Observation
    type
    BEHAVIORAL
Study design
allocation
RANDOMIZED
intervention Model
CROSSOVER
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
710
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Patients are considered a failure for this endpoint if they die or if they progress or relapse.
    measure
    Progression-Free Survival (PFS)
    time Frame
    Year 3
secondary Outcomes
  1. description
    The event is death from any cause, patients alive at the time of last observation are considered censored.
    measure
    Overall Survival (OS) for Standard Risk
    time Frame
    Years 1, 2, and 3
  2. description
    The event is death from any cause, patients alive at the time of last observation are considered censored.
    measure
    Overall Survival (OS) for High Risk
    time Frame
    Year 3
  3. 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.
    measure
    Cumulative Incidence of Progression/Relapse
    time Frame
    Year 3
  4. description
    TRM is defined as death occurring in a patient from causes other than relapse or progression.
    measure
    Cumulative Incidence of Treatment Related Mortality (TRM)
    time Frame
    Year 3
  5. 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.
    measure
    Interval From First to Second Transplantation
    time Frame
    Year 1
  6. description
    Incidence and severity of GVHD will be scored according to the BMT clinical trials network Manual of Procedures.
    measure
    Incidences of Graft Versus Host Disease (GVHD)
    time Frame
    Day 100
  7. description
    Incidence and severity of chronic GVHD will be scored according to the BMT clinical trials network Manual of Procedures.
    measure
    Incidences of Chronic GVHD
    time Frame
    Years 1 and 2
Full 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.
Source references
avail Ipds
  1. comment
    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.
    id
    BMT CTN-0102
    type
    Individual Participant Data Set
  2. id
    BMT CTN-0102
    type
    Study Protocol
  3. id
    BMT CTN-0102
    type
    Study Forms
references
  1. 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.
    pmid
    21962393
    type
    RESULT
  2. 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.
    pmid
    19029209
    type
    RESULT
  3. 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.
    pmid
    31756536
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice