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A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Cancer Type
Multiple Myeloma
Plasma cell neoplasm
Trial Phase
Phase I
Phase II
18 Years and older, Male and Female
Study Type
Protocol IDs
CR108901 (primary)
Study Sponsor
Janssen Research & Development, LLC


The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R[s]) and
schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for
the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab +
teclistamab in participants with relapsed or refractory multiple myeloma and
extramedullary disease (EMD) (Part 3).


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.


  1. Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  2. 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
  3. 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

Treatment Sites in Georgia

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.