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CompletedNCT02322320Updated May 11, 2020Results posted

Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)

A Phase 3 interventional study of Lenalidomide in Multiple Myeloma, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed at 42 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-05-11.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
273
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study is designed to compare long-term outcomes among patients randomized on the BMT CTN 0702 protocol (NCT01109004), "A Trial of Single Autologous Transplant with or without Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for Patients with Multiple Myeloma". It is hypothesized that use of novel anti-myeloma agents will improve long-term progression-free survival (PFS) after high-dose melphalan followed by autologous hematopoietic cell transplantation (HCT) as compared to a second autologous transplantation.

Read the detailed description

This study is designed to compare long-term outcomes among patients randomized on the BMT CTN 0702 protocol (NCT01109004). All patients who consent will be followed for death, progression, Second Primary Malignancies (SPMs), and Quality of Life (QOL). Patients who do not consent to the long-term follow-up mechanism or who have experienced progression on the BMT CTN 0702 study will be followed through the standard Center for International Blood and Marrow Transplant Research (CIBMTR) long-term follow-up mechanism. Additionally, patients who are eligible and are willing to continue with lenalidomide as maintenance therapy will be provided lenalidomide free of charge. These patients will continue to receive lenalidomide as maintenance therapy until disease progression or discontinuation due to toxicity, death, or withdrawal from the study. The endpoints assessed will include progression-free survival (PFS), overall survival (OS), event-free survival (EFS), incidence of second primary malignancies (SPM) and health quality of life (QOL).

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Conditions studied

  • Multiple Myeloma

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Keywords

  • Multiple Myeloma
  • Lenalidomide
  • Maintenance Therapy
  • Progression
  • Long-term
  • Anti-Myeloma Agents
  • Hematologic Disorders
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 273 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data as part of this study:

  1. Enrolled and randomized on the BMT CTN 0702 protocol.
  2. Alive at the completion of BMT CTN 0702 protocol specified follow-up defined as 4 years post-randomization.
  3. Patients without evidence of disease progression at the completion of BMT CTN 0702 protocol specified follow up.
  4. Signed Informed Consent Form.
  5. Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.

Inclusion Criteria for Optional Long-term Lenalidomide Maintenance Therapy:

Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data AND receive long-term lenalidomide maintenance therapy as part of this study:

  1. Enrolled and randomized to BMT CTN 0702.
  2. Completion of 3 years of maintenance therapy on BMT CTN 0702.
  3. Registered in the mandatory Revlimid REMS® program (formerly the RevAssist® for Study Participants (RASP) program), and be willing and able to comply with the requirements of the Revlimid REMS® program, including counseling, pregnancy testing, and phone surveys.
  4. Signed informed consent form.
  5. Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.

Exclusion criteria

Exclusion Criteria:

Patients who meet any of the following criteria will be ineligible to receive long-term lenalidomide maintenance therapy as part of this study:

  1. Patients who have evidence of disease progression prior to enrollment.
  2. Patients who were discontinued from BMT CTN 0702 lenalidomide maintenance therapy, for any reason, prior to the completion of the 3 years of 0702 maintenance.
  3. Female patients who are pregnant (positive - Beta Human Chorionic Gonadotropin) or breastfeeding.
  4. Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques during the length of lenalidomide maintenance therapy.
  5. Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide.
  6. Patients unwilling to take Deep Vein Thrombosis (DVT) prophylaxis.
  7. Patients who developed a second primary malignancy, excluding non-melanoma skin cancers after initiation of lenalidomide maintenance therapy on BMT CTN 0702.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
273 participants (actual)

Study arms

  • Active comparator
    Tandem Auto Transplant

    Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance

    Drug: Lenalidomide

  • Active comparator
    RVD Consolidation

    Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance

    Drug: Lenalidomide

  • Active comparator
    Lenalidomide Maintenance

    Initial autologous transplant followed by lenalidomide maintenance

    Drug: Lenalidomide

Interventions

  • DrugLenalidomide

    In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.

    Also known as: Revlimid™

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Progression-free Survival (PFS)

    This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate progression-free survival during the 5 year post-randomization follow-up period.

    Time frame: 5 years post-randomization in BMT CTN 0702

Secondary outcomes

  1. Percentage of Participants With Overall Survival (OS)

    This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Overall survival is defined as survival of death from any cause. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate overall survival during the 5 year post-randomization follow-up period.

    Time frame: 5 years post-randomization in BMT CTN 0702

  2. Percentage of Participants With Event-free Survival (EFS)

    This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Event-free survival is defined as survival without disease progression, second primary malignancy, and death. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate event-free survival during the 5 year post-randomization follow-up period.

    Time frame: 5 years post-randomization in BMT CTN 0702

  3. Percentage of Participants With Secondary Primary Malignancies (SPM)

    This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). SPM is defined as development of any second malignancy, excluding non-melanoma skin cancers. To account for loss to follow-up, the Aalen-Johansen estimator was used to estimate the cumulative incidence of SPM during the 5 year post-randomization follow-up period. The development of any SPMs excludes non-melanoma skin cancers. Death without SPMs will be considered a competing risk for this event. The cumulative incidence of SPMs will be compared between treatment arms.

    Time frame: 5 years post-randomization in BMT CTN 0702

  4. Percentage of Participants With Disease Progression

    This analysis includes all randomized subjects from BMT CTN 0702, classified by their treatment assignment (intention-to-treat). Disease progression is defined as progression of multiple myeloma, including one or more of the following: * Reappearance of serum monoclonal paraprotein at a level \>= 0.5 g/dL * 24-hour urine protein electrophoresis of at least 200mg paraprotein/24 hours * Abnormal free light chain levels of \>10 mg/dl, only in patients without measurable paraprotein in serum and urine * At least 10% plasma cells in a bone marrow aspirate or trephine biopsy * Definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of new bone lesions or soft tissue plasmacytomas * Development of hypercalcemia (corrected serum Ca \>11.5 mg/dL or \>2.8 mmol/L) not attributable to other causes To account for loss to follow-up, the Aalen-Johansen estimator was used to estimate the cumulative incidence of progression during the follow-up period.

    Time frame: 5 years post-randomization in BMT CTN 0702

07

Results

Posted May 11, 2020

Participant flow

Participant flow — Overall Study
MilestoneTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Started988689
Completed988689
Not completed000

Outcome measures

PrimaryPercentage of Participants With Progression-free Survival (PFS)

This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate progression-free survival during the 5 year post-randomization follow-up period.

Time frame:
5 years post-randomization in BMT CTN 0702
Reported as:
Number · percentage of participants
Percentage of Participants With Progression-free Survival (PFS)
percentage of participantsTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Percentage of Participants With Progression-free Survival (PFS)47.7 (41.1 to 53.8)44.1 (38.0 to 50.3)45.0 (38.8 to 51.2)
Statistical analysis
  • Tandem Auto Transplant vs RVD Consolidation · Log Rank · p = 0.60 (The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.)The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
  • Tandem Auto Transplant vs Lenalidomide Maintenance · Log Rank · p = 0.35 (The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.)The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
  • RVD Consolidation vs Lenalidomide Maintenance · Log Rank · p = 0.68 (The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.)The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
SecondaryPercentage of Participants With Overall Survival (OS)

This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Overall survival is defined as survival of death from any cause. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate overall survival during the 5 year post-randomization follow-up period.

Time frame:
5 years post-randomization in BMT CTN 0702
Reported as:
Number · percentage of participants
Percentage of Participants With Overall Survival (OS)
percentage of participantsTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Percentage of Participants With Overall Survival (OS)74.7 (69.1 to 80.0)75.4 (70.0 to 80.6)76.4 (71.0 to 81.5)
Statistical analysis
  • Tandem Auto Transplant vs RVD Consolidation · Log Rank · p = 0.57 (The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.)The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
  • Tandem Auto Transplant vs Lenalidomide Maintenance · Log Rank · p = 0.38 (The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.)The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
  • RVD Consolidation vs Lenalidomide Maintenance · Log Rank · p = 0.77 (The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.)The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
SecondaryPercentage of Participants With Event-free Survival (EFS)

This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Event-free survival is defined as survival without disease progression, second primary malignancy, and death. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate event-free survival during the 5 year post-randomization follow-up period.

Time frame:
5 years post-randomization in BMT CTN 0702
Reported as:
Number · percentage of participants
Percentage of Participants With Event-free Survival (EFS)
percentage of participantsTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Percentage of Participants With Event-free Survival (EFS)44.2 (38.0 to 50.5)42.1 (36.1 to 48.3)42.4 (36.4 to 48.6)
Statistical analysis
  • Tandem Auto Transplant vs RVD Consolidation · Log Rank · p = 0.67 (The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.)The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
  • Tandem Auto Transplant vs Lenalidomide Maintenance · Log Rank · p = 0.20 (The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.)The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
  • RVD Consolidation vs Lenalidomide Maintenance · Log Rank · p = 0.40 (The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.)The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
SecondaryPercentage of Participants With Secondary Primary Malignancies (SPM)

This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). SPM is defined as development of any second malignancy, excluding non-melanoma skin cancers. To account for loss to follow-up, the Aalen-Johansen estimator was used to estimate the cumulative incidence of SPM during the 5 year post-randomization follow-up period. The development of any SPMs excludes non-melanoma skin cancers. Death without SPMs will be considered a competing risk for this event. The cumulative incidence of SPMs will be compared between treatment arms.

Time frame:
5 years post-randomization in BMT CTN 0702
Reported as:
Number · percentage of participants
Percentage of Participants With Secondary Primary Malignancies (SPM)
percentage of participantsTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Percentage of Participants With Secondary Primary Malignancies (SPM)10.8 (7.2 to 15.1)7.9 (4.9 to 11.6)7.2 (4.3 to 10.8)
Statistical analysis
  • Tandem Auto Transplant vs RVD Consolidation · Gray's test · p = 0.43 (The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.)Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
  • Tandem Auto Transplant vs Lenalidomide Maintenance · Gray's test · p = 0.70 (The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.)Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
  • RVD Consolidation vs Lenalidomide Maintenance · Gray's test · p = 0.70 (The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.)Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
SecondaryPercentage of Participants With Disease Progression

This analysis includes all randomized subjects from BMT CTN 0702, classified by their treatment assignment (intention-to-treat). Disease progression is defined as progression of multiple myeloma, including one or more of the following: * Reappearance of serum monoclonal paraprotein at a level \>= 0.5 g/dL * 24-hour urine protein electrophoresis of at least 200mg paraprotein/24 hours * Abnormal free light chain levels of \>10 mg/dl, only in patients without measurable paraprotein in serum and urine * At least 10% plasma cells in a bone marrow aspirate or trephine biopsy * Definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of new bone lesions or soft tissue plasmacytomas * Development of hypercalcemia (corrected serum Ca \>11.5 mg/dL or \>2.8 mmol/L) not attributable to other causes To account for loss to follow-up, the Aalen-Johansen estimator was used to estimate the cumulative incidence of progression during the follow-up period.

Time frame:
5 years post-randomization in BMT CTN 0702
Reported as:
Number · percentage of participants
Percentage of Participants With Disease Progression
percentage of participantsTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Percentage of Participants With Disease Progression48.8 (42.5 to 55.2)54.3 (48.1 to 60.4)54.2 (48.0 to 60.4)

Adverse events

Collected over 22 months post-enrollment to BMT CTN 07LT. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tandem Auto Transplant4/98 (4.1%)6/98 (6.1%)0/98 (0%)
RVD Consolidation4/86 (4.7%)10/86 (11.6%)0/86 (0%)
Lenalidomide Maintenance2/89 (2.2%)6/89 (6.7%)0/89 (0%)
Most frequent serious events
Showing 10 of 25
Most frequent serious events
EventTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Cervical vertebral fractureInjury, poisoning and procedural complications0/981/860/89
Subdural haematomaInjury, poisoning and procedural complications0/981/861/89
Liver function test increasedInvestigations0/981/860/89
Acute lymphocytic leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/981/860/89
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/981/860/89
Colon cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/981/860/89
Hodgkin's diseaseNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/981/861/89
Malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/981/860/89
Myelodysplastic syndromeNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/981/860/89
Renal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/981/860/89

Baseline characteristics

Age, Continuous
Age, Continuous(years)Tandem Auto TransplantRVD ConsolidationLenalidomide MaintenanceTotal
Median55 (28 to 70)56 (28 to 69)57 (31 to 66)56 (28 to 70)
Sex: Female, Male
Sex: Female, Male(Participants)Tandem Auto TransplantRVD ConsolidationLenalidomide MaintenanceTotal
Female403134105
Male585555168
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Tandem Auto TransplantRVD ConsolidationLenalidomide MaintenanceTotal
Hispanic or Latino115218
Not Hispanic or Latino817784242
Unknown or Not Reported64313
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Tandem Auto TransplantRVD ConsolidationLenalidomide MaintenanceTotal
Asian25411
Black or African American22101648
White686968205
Multiracial2013
Other1001
Unknown or Not Reported3205
Karnofsky Performance Score (KPS)
Karnofsky Performance Score (KPS)(Participants)Tandem Auto TransplantRVD ConsolidationLenalidomide MaintenanceTotal
90-100786063201
70-8020262672
Diseae Risk at BMT CTN 0702 Enrollment
Diseae Risk at BMT CTN 0702 Enrollment(Participants)Tandem Auto TransplantRVD ConsolidationLenalidomide MaintenanceTotal
Standard736572210
High25211763
08

Study locations

42 sites
  • Arizona Cancer Center
    Tucson, Arizona 85724, United States
  • City of Hope National Medical Center
    Duarte, California 91010-3000, United States
  • University of California, San Diego 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
    Gainesville, Florida 32610, United States
  • University of Miami
    Miami, Florida 33624, United States
  • H. Lee Moffitt Cancer Center
    Tampa, Florida 33624, United States
  • BMT Group of Georgia (Northside Hospital)
    Atlanta, Georgia 30342, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • University of Kansas Hospital
    Kansas City, Kansas 66160, United States
  • Louisiana State University Health Sciences Center
    Shreveport, Louisiana 71130, United States
  • DFCI, Brigham and Womens Hospital
    Boston, Massachusetts 02114, United States
  • University of Michigan Medical Center
    Ann Arbor, Michigan 48105-2967, United States
  • Karmanos Cancer Institute/BMT
    Detroit, Michigan 48201, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • Washington University, Barnes Jewish Hospital
    Saint Louis, Missouri 63110, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198-7680, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Roswell Park Cancer Center
    Buffalo, New York 14263, United States
  • North Shore University Hospital
    Lake Success, New York 11042, United States
  • Mount Sinai Medical Center
    New York, New York 10029, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10174, United States
  • University of North Carolina Hospital at Chapel Hill
    Chapel Hill, North Carolina 27599-7305, United States
  • Duke University Medical Center
    Durham, North Carolina 27705, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • Jewish Hospital BMT Program
    Cincinnati, Ohio 45236, United States
  • University Hospitals of Cleveland/Case Western
    Cleveland, Ohio 44106-5061, United States
  • Ohio State/Arthur G. James Cancer Hospital
    Columbus, Ohio 43210, United States
  • University of Oklahoma Medical Center
    Oklahoma City, Oklahoma 73104, United States
  • Oregon Health & Science University
    Portland, Oregon 97239-3098, United States
  • Penn State College of Medicine, The Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • University of Pennsylvania Cancer Center
    Philadelphia, Pennsylvania 19104, United States
  • Sarah Cannon Blood & Marrow Transplant Program
    Nashville, Tennessee 37203, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232-8210, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
  • University of Texas/MD Anderson CRC
    Houston, Texas 77030, United States
  • Texas Transplant Institute
    San Antonio, Texas 78229, United States
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109-1024, United States
  • West Virginia University Hospital
    Morgantown, West Virginia 26506, United States
  • University of Wisconsin Hospital & Clinics
    Madison, Wisconsin 53792-5156, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53211, United States
09

References and documents

Study documents

  • Study protocol · Apr 28, 2016
  • Statistical analysis plan · May 15, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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).

Supporting information: Study protocol, Icf

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02322320
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program
Responsible party
Sponsor
First posted
Dec 23, 2014
Start date
Mar 2015
Primary completion
Jun 7, 2019
Completion
Jun 7, 2019
Results posted
May 11, 2020
Last update
May 11, 2020

Study contacts

Mary Horowitz, MD
study director · Center for International Blood and Marrow Transplant Research

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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