A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
18 Years and older, Male and Female
CR108920 (primary)
NCI-2021-02134
2017-002400-26
2023-504581-29-00
TALMMY1001-PT3
Summary
The purpose of this study is to evaluate the efficacy and safety of talquetamab in
participants with relapsed or refractory multiple myeloma at the recommended Phase 2
dose(s) (RP2Ds) (Part 3).
Objectives
Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions,
increased susceptibility to infections, hypercalcemia, and renal failure. Talquetamab is
a humanized immunoglobulin G4 proline, alanine, alanine (IgG4PAA) bispecific antibody
designed to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the
CD3 molecule found on T lymphocytes (T cell). 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 (30 days (+ 7 days)] visit); and a
post-treatment follow-up phase (until the end of study unless the participant has died,
is lost to follow up or has withdrawn consent). Total duration of study is up to 2 years
(after the last participant receives their first dose). Safety, pharmacokinetics (PK),
laboratory tests, and questionnaire will be assessed at specified time points during this
study. Participants safety and study conduct will be monitored throughout the study. The
corresponding study (NCT03399799) is the Phase 1 part of the study and TALMMY1001- Part 3
is the Phase 2 part of the study.
Eligibility
- Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
- Part 3: Measurable disease cohort A, cohort B, cohort C, and cohort D: multiple myeloma must be measurable by central laboratory assessment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin [hCG]) or urine
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
Treatment Sites in Georgia
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