Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 1/11/2019 |
Start Date: | March 2015 |
End Date: | June 30, 2019 |
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.
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.
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).
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).
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:
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.
We found this trial at
42
sites
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
Phone: 336-716-7972
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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University of Miami A private research university with more than 15,000 students from around the...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-343-7893
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1 Gustave L Levy Pl # 271
New York, New York 10029
New York, New York 10029
(212) 241-6500
Phone: 212-241-6021
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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101 Manning Dr
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
(919) 966-4131
Phone: 919-966-7313
University of North Carolina Hospital at Chapel Hill The UNC Health Care System is a...
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1653 W. Congress Parkway
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 942-5000
Phone: 612-942-3696
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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1801 Inwood Rd
Dallas, Texas 75390
Dallas, Texas 75390
(214) 645-3300
Phone: 214-648-5102
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
Denver, Colorado 80218
720-754-4800
Phone: 303-388-4876
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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3450 Hull Road
Gainesville, Florida 32610
Gainesville, Florida 32610
Phone: 352-273-8022
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30 Prospect Ave
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
(201) 996-2000
Phone: 201-996-5828
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hershey, Pennsylvania 17033
Phone: 717-531-6585
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
Phone: 608-262-8690
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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