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

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Trial Identification

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

Interventions

Lenalidomide

Study Description

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).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Mary Horowitz, MD

Affiliation: Center for International Blood and Marrow Transplant Research

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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