Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation - MajesTEC-4
Summary
This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.
Arms & interventions
- DrugTeclistamab
Teclistamab will be administered via a subcutaneous injection (SC)
- DrugLenalidomide
Lenalidomide will be administered orally
Outcome measures
Primary
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of disease progression (as assessed by IMWG criteria) or death due to any cause, whichever occurs first.
Time frame: from randomization to the date of disease progression or death (approximately up to 8 years)
Minimal Residual Disease (MRD)-negative Complete Response (CR)
12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months, as determined by next-generation flow cytometry (NGF) with sensitivity of 10\^-5, prior to progressive disease or subsequent anti-myeloma therapy, whichever is earlier, and who also achieve CR of better, according to IMWG criteria.
Time frame: at month 12
Secondary
Comparison of efficacy
Time frame: from randomization to the date of disease progression or death (approximately up to 8 years)
Overall Survival (OS)
Time frame: from the date of from randomization to the date the subject's death, assessed up to 8 years]
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQ-C30) score and the difference between-treatment arms
Time frame: baseline up to 8 years
EQ-5D-5L health utility values and the difference between-treatment arms
Time frame: baseline up to 8 years
MySIm-Q Symptom and Impacts in Patients With Multiple Myeloma and the difference between treatment arms
Time frame: baseline up to 8 years
PRO-CTCAE to evaluate symptomatic toxicities by self-report and the difference between treatment arms
Time frame: baseline up to week 24
PGIS to evaluate the patient global impression of severity of the Multiple Myeloma and the difference between treatment arms
Time frame: baseline up to 8 years
Eligibility criteria
Study locations (42)
Banner University Medical Center Tucson, University of Arizona
Phoenix, Arizona, 85004
UCLA Medical Center
Los Angeles, California, 90095
University of California-Davis Cancer Center
Sacramento, California, 95817
University of California, San Diego (UCSD) Medical Center
San Diego, California, 92093
University of Colorado Hospital
Aurora, Colorado, 80045
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Yale New Haven Hospital
New Haven, Connecticut, 06519
Christiana Care
Newark, Delaware, 19718
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
AdventHealth/Blood & Marrow Transplant Center, Florida Hospital Medical Group
Orlando, Florida, 32804
Moffitt at Memorial Healthcare System
Tampa, Florida, 33612
Emory University Hospital
Atlanta, Georgia, 30322
University of Chicago
Chicago, Illinois, 3000168
University of Illinois Medical Center at Chicago
Chicago, Illinois, 60612
Greenebaum Cancer Center UM of MD
Baltimore, Maryland, 21201
John Hopkins
Baltimore, Maryland, 21218
Tufts Medical Center
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Henry Ford St. John Hospital
Grosse Pointe Woods, Michigan, 3000169
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Mount Sinai Medical Center - 2
New York, New York, 10029
Montefiore Medical Cente
The Bronx, New York, 10467
Levine Cancer Institute
Charlotte, North Carolina, 28204
Duke University
Durham, North Carolina, 27710
East Carolina University
Greenville, North Carolina, 27858
University of Cincinnati
Cincinnati, Ohio, 45221
Seidman Cancer Center-University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Ohio State Medical Center, James Cancer Center
Columbus, Ohio, 43210
Ohio Health Research Institute
Columbus, Ohio, 43214
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Penn Medicine Lancaster General
Lancaster, Pennsylvania, 17602
Abramson Cancer Center University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Gibbs Cancer Center
Spartanburg, South Carolina, 29303
Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee, 37232
Houston Methodist Hospital
Houston, Texas, 77030
Virginia Oncology Associates
Norfolk, Virginia, 23502
St Vincent HSHS (Green Bay Oncology)
Green Bay, Wisconsin, 54301
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226