A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (RedirecTT-1)

Last Updated   June 20, 2024 - 21:00

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 1
    Researchers 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
    40 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

Locations in:
United States, Spain, South Korea, Japan, Israel, Canada, Australia
Country (7) City or Province (40) Status
United States Atlanta, GA Emory University
RECRUITING
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 And 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 Vincents Hospital Melbourne
RECRUITING
Australia Perth, WA Royal Perth Hospital
RECRUITING
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