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Brief Title: Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)
Official Title: Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN #07LT)
Study ID: NCT02322320
Brief 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.
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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Arizona Cancer Center, Tucson, Arizona, United States
City of Hope National Medical Center, Duarte, California, United States
University of California, San Diego Medical Center, La Jolla, California, United States
Stanford Hospital and Clinics, Stanford, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
University of Florida College of Medicine, Gainesville, Florida, United States
University of Miami, Miami, Florida, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
BMT Group of Georgia (Northside Hospital), Atlanta, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Kansas Hospital, Kansas City, Kansas, United States
Louisiana State University Health Sciences Center, Shreveport, Louisiana, United States
DFCI, Brigham and Womens Hospital, Boston, Massachusetts, United States
University of Michigan Medical Center, Ann Arbor, Michigan, United States
Karmanos Cancer Institute/BMT, Detroit, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Washington University, Barnes Jewish Hospital, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Roswell Park Cancer Center, Buffalo, New York, United States
North Shore University Hospital, Lake Success, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
University of North Carolina Hospital at Chapel Hill, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Jewish Hospital BMT Program, Cincinnati, Ohio, United States
University Hospitals of Cleveland/Case Western, Cleveland, Ohio, United States
Ohio State/Arthur G. James Cancer Hospital, Columbus, Ohio, United States
University of Oklahoma Medical Center, Oklahoma City, Oklahoma, United States
Oregon Health & Science University, Portland, Oregon, United States
Penn State College of Medicine, The Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Sarah Cannon Blood & Marrow Transplant Program, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
University of Texas/MD Anderson CRC, Houston, Texas, United States
Texas Transplant Institute, San Antonio, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
West Virginia University Hospital, Morgantown, West Virginia, United States
University of Wisconsin Hospital & Clinics, Madison, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Name: Mary Horowitz, MD
Affiliation: Center for International Blood and Marrow Transplant Research
Role: STUDY_DIRECTOR