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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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).

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 groups in NCT02322320
Study groupRoleWhat they receive
Tandem Auto TransplantActive comparatorInitial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Receives: Drug: Lenalidomide
RVD ConsolidationActive comparatorInitial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
Receives: Drug: Lenalidomide
Lenalidomide MaintenanceActive comparatorInitial 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.

  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.

    Measured: 5 years post-randomization in BMT CTN 0702

Secondary outcomes (4)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    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.

  1. First posted23 Dec 2014 (estimated)
  2. Study startMar 2015
  3. Primary completion7 Jun 2019
  4. Study completion7 Jun 2019

Resources

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)
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
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).

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?

On the ClinicalTrials.gov record for NCT02322320.

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.

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