Multiple MyelomaPhase 3NCT02322320
Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)
A Phase 3 study testing Lenalidomide in people with Multiple Myeloma, run by National Heart, Lung, and Blood Institute (NHLBI) at 42 sites in United States.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 42 sitesUnited States
- Study dates
- Mar 2015to 7 Jun 2019
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data as part of this study:
- Enrolled and randomized on the BMT CTN 0702 protocol.
- Alive at the completion of BMT CTN 0702 protocol specified follow-up defined as 4 years post-randomization.
- Patients without evidence of disease progression at the completion of BMT CTN 0702 protocol specified follow up.
- Signed Informed Consent Form.
- Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.
Show all 13Show fewer
- 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:
- Enrolled and randomized to BMT CTN 0702.
- Completion of 3 years of maintenance therapy on BMT CTN 0702.
- 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.
- Signed informed consent form.
- Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.
Who cannot join
- Patients who meet any of the following criteria will be ineligible to receive long-term lenalidomide maintenance therapy as part of this study:
- Patients who have evidence of disease progression prior to enrollment.
- 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.
- Female patients who are pregnant (positive - Beta Human Chorionic Gonadotropin) or breastfeeding.
- 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.
- Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide.
- Patients unwilling to take Deep Vein Thrombosis (DVT) prophylaxis.
- Patients who developed a second primary malignancy, excluding non-melanoma skin cancers after initiation of lenalidomide maintenance therapy on BMT CTN 0702.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48105-2967
BMT Group of Georgia (Northside Hospital)
Atlanta, Georgia, 30342
DFCI, Brigham and Womens Hospital
Boston, Massachusetts, 02114
Roswell Park Cancer Center
Buffalo, New York, 14263
University of North Carolina Hospital at Chapel Hill
Chapel Hill, North Carolina, 27599-7305
Rush University Medical Center
Chicago, Illinois, 60612
Jewish Hospital BMT Program
Cincinnati, Ohio, 45236
University Hospitals of Cleveland/Case Western
Cleveland, Ohio, 44106-5061
Ohio State/Arthur G. James Cancer Hospital
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Karmanos Cancer Institute/BMT
Detroit, Michigan, 48201
City of Hope National Medical Center
Duarte, California, 91010-3000
Duke University Medical Center
Durham, North Carolina, 27705
University of Florida College of Medicine
Gainesville, Florida, 32610
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Penn State College of Medicine, The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Texas/MD Anderson CRC
Houston, Texas, 77030
University of Kansas Hospital
Kansas City, Kansas, 66160
University of California, San Diego Medical Center
La Jolla, California, 92093
North Shore University Hospital
Lake Success, New York, 11042
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792-5156
University of Miami
Miami, Florida, 33624
Medical College of Wisconsin
Milwaukee, Wisconsin, 53211
University of Minnesota
Minneapolis, Minnesota, 55455
West Virginia University Hospital
Morgantown, West Virginia, 26506
Sarah Cannon Blood & Marrow Transplant Program
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8210
Mount Sinai Medical Center
New York, New York, 10029
Memorial Sloan-Kettering Cancer Center
New York, New York, 10174
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239-3098
Texas Transplant Institute
San Antonio, Texas, 78229
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71130
Washington University, Barnes Jewish Hospital
St Louis, Missouri, 63110
Stanford Hospital and Clinics
Stanford, California, 94305
H. Lee Moffitt Cancer Center
Tampa, Florida, 33624
Arizona Cancer Center
Tucson, Arizona, 85724
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN #07LT)
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).
- Conditions
- Multiple Myeloma
- Being tested
- Lenalidomide
- Keywords
- Multiple Myeloma, Lenalidomide, Maintenance Therapy, Progression, Long-term, Anti-Myeloma Agents, Hematologic Disorders
- Medical subject headings
- Multiple Myeloma, Disease Progression, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid™
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.
| Study group | Role | What they receive |
|---|---|---|
| Tandem Auto Transplant | Active comparator | Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Receives: Drug: Lenalidomide |
| RVD Consolidation | Active comparator | Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance Receives: Drug: Lenalidomide |
| Lenalidomide Maintenance | Active comparator | Initial autologous transplant followed by lenalidomide maintenance Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years post-randomization in BMT CTN 0702
Secondary outcomes (4)
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.
Measured: 5 years post-randomization in BMT CTN 0702
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.
Measured: 5 years post-randomization in BMT CTN 0702
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.
Measured: 5 years post-randomization in BMT CTN 0702
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.
Measured: 5 years post-randomization in BMT CTN 0702
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startMar 2015
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 273 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
- NCT02322320
- Sponsor's protocol ID
- BMTCTN07LT
- Other IDs
- U01HL069294-05
- Status last verified
- Sep 2019
- First submitted
- 17 Dec 2014
- Last updated
- 11 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN #07LT)
- ClinicalTrials.gov ID
- NCT02322320
- Acronym / sponsor ID
- BMTCTN07LT
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Lenalidomide, Maintenance Therapy, Progression, Long-term, Anti-Myeloma Agents, Hematologic Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 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
- Mar 2015 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Posted 11 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tandem Auto Transplant | Active comparator | Drug: LenalidomideInitial autologous transplant followed by a second autologous transplant and lenalidomide maintenance |
| RVD Consolidation | Active comparator | Drug: LenalidomideInitial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance |
| Lenalidomide Maintenance | Active comparator | Drug: LenalidomideInitial autologous transplant followed by lenalidomide maintenance |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data as part of this study:
- Enrolled and randomized on the BMT CTN 0702 protocol.
- Alive at the completion of BMT CTN 0702 protocol specified follow-up defined as 4 years post-randomization.
- Patients without evidence of disease progression at the completion of BMT CTN 0702 protocol specified follow up.
- Signed Informed Consent Form.
Key exclusion criteria (8 listed)
- Patients who meet any of the following criteria will be ineligible to receive long-term lenalidomide maintenance therapy as part of this study:
- Patients who have evidence of disease progression prior to enrollment.
- 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.
- Female patients who are pregnant (positive - Beta Human Chorionic Gonadotropin) or breastfeeding.
- 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.
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 |
|---|---|---|
| LenalidomideAlso: Revlimid™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. | Drug | Lenalidomide Maintenance, RVD Consolidation, Tandem Auto Transplant |
Primary outcome
Percentage of Participants With Progression-free Survival (PFS)
Time frame: 5 years post-randomization in BMT CTN 0702
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.
4 secondary outcomes
Percentage of Participants With Overall Survival (OS)
Time frame: 5 years post-randomization in BMT CTN 0702
Percentage of Participants With Event-free Survival (EFS)
Time frame: 5 years post-randomization in BMT CTN 0702
Percentage of Participants With Secondary Primary Malignancies (SPM)
Time frame: 5 years post-randomization in BMT CTN 0702
Percentage of Participants With Disease Progression
Time frame: 5 years post-randomization in BMT CTN 0702
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- National Marrow Donor ProgramLink provided by the sponsor.
- 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
42 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 Lenalidomide in people with Multiple Myeloma, run by National Heart, Lung, and Blood Institute (NHLBI) at 42 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 13 inclusion and 8 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 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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 11 May 2020). 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?
Percentage of Participants With Progression-free Survival (PFS) (time frame: 5 years post-randomization in BMT CTN 0702). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2020.