A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (RedirecTT-1)
Last Updated   March 27, 2024 - 21:04
OVERVIEW
-
Gender
all -
Age
years -
Phase
phase 1Researchers test a new drug or treatment in a small group of people for the first time to gather information on its safety, dosing, and side effects. -
Sites
sites -
Status
Recruiting
SUMMARY
Multiple myeloma is a malignant plasma cell disorder characterized by production of monoclonal proteins (M proteins), which are comprised of pathologic immunoglobulins (Ig) or fragments of such, which have subsequently lost their normal function. Rationale for combining talquetamab and teclistamab is the targeting of multiple proteins on the surface of multiple myeloma cells resulting in cell lysis. This study consists of 3 periods: screening phase (up to 28 days), treatment phase (start of study drug administration and continues until the completion of the end of treatment [EOT] visit); and a post-treatment follow-up phase (after end of treatment and up to 16 weeks after last dose of study drug(s) for each participant). End of study is defined as 2 years after the last participant has received his or her initial dose of the treatment combination. Total duration of study is Approximately 5 years. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points during this study. Participants safety and study conduct will be monitored throughout the study.
CONDITIONS
- Multiple Myeloma
ELIGIBILITY
Inclusion Criteria:
* Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
* Part 1 and 2: Participant could not tolerate or has disease that is relapsed or refractory to established therapies, including the last line of therapy. Part 3: (a) Relapsed or refractory disease, and exposed to a PI, IMiD, and an anti-CD38 mAb; (b) Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
* Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration. Part 3: ECOG performance status grade of 0, 1, or 2 at screening and immediately before the start of study drug administration
Exclusion Criteria:
* All Parts: Targeted therapy, epigenetic therapy, or treatment with an investigational treatment or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less. Part 3: prior BCMA targeted bispecific antibody therapy; prior GPRC5D targeted therapy
* All Parts: Allogeneic stem cell transplant within 6 months before the first dose of study treatment.
* All Parts: Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma.
* All Parts: Active plasma cell leukemia (greater than [>]2.0*10^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M- protein, and skin changes), or primary amyloid light chain amyloidosis
DETAILS
Multiple myeloma is a malignant plasma cell disorder characterized by production of monoclonal proteins (M proteins), which are comprised of pathologic immunoglobulins (Ig) or fragments of such, which have subsequently lost their normal function. Rationale for combining talquetamab and teclistamab is the targeting of multiple proteins on the surface of multiple myeloma cells resulting in cell lysis. This study consists of 3 periods: screening phase (up to 28 days), treatment phase (start of study drug administration and continues until the completion of the end of treatment \[EOT\] visit); and a post-treatment follow-up phase (after end of treatment and up to 16 weeks after last dose of study drug(s) for each participant). End of study is defined as 2 years after the last participant has received his or her initial dose of the treatment combination. Total duration of study is Approximately 5 years. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points during this study. Participants safety and study conduct will be monitored throughout the study.
LOCATIONS
Country (7) | City or Province (39) | Status |
United States | Birmingham, AL University of Alabama at Birmingham, Comprehensive Cancer Center |
RECRUITING
|
United States | Charlotte, NC Atrium Health |
RECRUITING
|
United States | Cleveland, OH Cleveland Clinic |
RECRUITING
|
United States | Denver, CO Colorado Blood Cancer Institute |
RECRUITING
|
United States | Houston, TX The University of Texas MD Anderson Cancer Center |
RECRUITING
|
United States | Little Rock, AR University of Arkansas for Medical Sciences |
RECRUITING
|
United States | New York, NY Memorial Sloan Kettering Cancer Center |
RECRUITING
|
United States | New York, NY Mount Sinai Medical Center |
RECRUITING
|
United States | Portland, OR Oregon Health & Science University |
RECRUITING
|
United States | Rochester, MN Mayo Clinic |
RECRUITING
|
United States | Saint Louis, MO Washington University in St. Louis |
RECRUITING
|
United States | Winston-Salem, NC Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center |
RECRUITING
|
Spain | Badalona, BA Hosp. Univ. Germans Trias I Pujol |
RECRUITING
|
Spain | Barcelona, BA Hosp. Clinic de Barcelona |
RECRUITING
|
Spain | L Hospitalet De Llobregat, BA Inst. Cat. Doncologia-H Duran I Reynals |
RECRUITING
|
Spain | Madrid, MD Hosp. Univ. Fund. Jimenez Diaz |
RECRUITING
|
Spain | Madrid, MD UNIV. HOSP. October 12 |
RECRUITING
|
Spain | Pamplona Clinica Univ. de Navarra |
RECRUITING
|
Spain | Salamanca, SL Hosp. Clinico Univ. de Salamanca |
RECRUITING
|
Spain | Santander, CT Hosp. Univ. Marques de Valdecilla |
RECRUITING
|
South Korea | Seoul Asan Medical Center |
RECRUITING
|
South Korea | Seoul Samsung Medical Center |
RECRUITING
|
South Korea | Seoul Seoul National University Hospital |
RECRUITING
|
South Korea | Seoul Severance Hospital Yonsei University Health System |
RECRUITING
|
South Korea | Seoul The Catholic University of Korea Seoul St. Mary's Hospital |
RECRUITING
|
Japan | Kanazawa Kanazawa University Hospital |
RECRUITING
|
Japan | Nagoya Nagoya City University Hospital |
RECRUITING
|
Japan | Osaka, 27 Osaka University Hospital |
RECRUITING
|
Japan | Sendai-shi, 04 Tohoku University Hospital |
RECRUITING
|
Japan | Shibuya, 13 Japanese Red Cross Medical Center |
RECRUITING
|
Israel | Jerusalem Hadassah Medical Center |
RECRUITING
|
Israel | Ramat Gan Sheba Medical Center |
RECRUITING
|
Israel | Tel-Aviv Tel-Aviv Sourasky Medical Center |
RECRUITING
|
Canada | Calgary, AB Tom Baker Cancer Centre |
RECRUITING
|
Canada | Edmonton, AB Alberta Health Services |
RECRUITING
|
Canada | Montreal, QC McGill University Health Centre |
RECRUITING
|
Canada | Toronto, ON Princess Margaret Cancer Centre University Health Network |
RECRUITING
|
Australia | Fitzroy, VIC St. Vincent's Hospital Melbourne |
RECRUITING
|
Australia | Perth, WA Royal Perth Hospital |
RECRUITING
|
Indicates 50+ sites in this region: click to zoom in.
Indicates 10+ sites in this region: click to zoom in.
Indicates < 10 sites in this region: click to zoom in.
Corresponds to individual site.