A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma (TRIMM-3)

Last Updated   April 24, 2024 - 21:08

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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
    18 sites
  • Status
    Recruiting

SUMMARY

Multiple myeloma is a malignant plasma cell disorder that accounts for approximately 10 percent (%) of all hematologic cancers, making it the second most common hematologic malignancy. The overall rationale of this study is that talquetamab or teclistamab in combination with a PD-1 inhibitor may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study will evaluate the clinical hypothesis that talquetamab or teclistamab can be safely administered at the selected dose when combined with a PD-1 inhibitor. The study will consist of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion) and a post treatment follow-up. End of study is defined as last study assessment for last participant in study. Total duration of study is up to 2 years 5 months. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points.

CONDITIONS

  • Relapsed/ Refractory Multiple Myeloma

ELIGIBILITY

Inclusion Criteria:

* Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria

* Participants with relapsed or refractory disease that are not a candidate for available therapy with established clinical benefit

* Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); b) Urine M-protein level >= 200 milligrams (mg) per 24 hours; c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio

* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

* Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene -modified adoptive cell therapy or autologous stem cell transplant within 3 months)

* Prior therapy with PD-1 inhibitors, allogeneic stem cell transplant or solid organ transplant

* Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis

* Active Central Nervous System (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required

* Live, attenuated vaccine within 4 weeks before the first dose of study treatment

* Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia [any grade] or peripheral neuropathy to Grade <= 2)

* Received a cumulative dose of corticosteroids equivalent to >= 140 milligrams (mg) of prednisone within the 14-day period before the start of study treatment administration

DETAILS

Multiple myeloma is a malignant plasma cell disorder that accounts for approximately 10 percent (%) of all hematologic cancers, making it the second most common hematologic malignancy. The overall rationale of this study is that talquetamab or teclistamab in combination with a PD-1 inhibitor may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study will evaluate the clinical hypothesis that talquetamab or teclistamab can be safely administered at the selected dose when combined with a PD-1 inhibitor. The study will consist of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion) and a post treatment follow-up. End of study is defined as last study assessment for last participant in study. Total duration of study is up to 2 years 5 months. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points.

LOCATIONS

Locations in:
United States, Spain, Germany, France
Country (4) City or Province (18) Status
United States Denver, CO Colorado Blood Cancer Institute
RECRUITING
United States Nashville, TN Sarah Cannon Research Institute
RECRUITING
United States Nashville, TN Vanderbilt - Ingram Cancer Center
RECRUITING
United States New York, NY Icahn School of Medicine at Mount Sinai
RECRUITING
United States New York, NY Memorial Sloan Kettering Cancer Center
RECRUITING
United States Winston-Salem, NC Wake Forest Baptist Medical Center
RECRUITING
Spain Badalona, BA Hosp. Univ. Germans Trias I Pujol
RECRUITING
Spain Madrid, MD Hosp. Univ. Fund. Jimenez Diaz
RECRUITING
Spain Pamplona Clinica Univ. de Navarra
RECRUITING
Spain Salamanca, SL Hosp. Clinico Univ. de Salamanca
RECRUITING
Germany Dresden, SN Universitatsklinikum Carl Gustav Carus Dresden
RECRUITING
Germany Hamburg, HH Universitaetsklinikum Hamburg Eppendorf
RECRUITING
Germany Heidelberg, BW Universitaetsklinikum Heidelberg
RECRUITING
Germany Wuerzburg Universitatsklinikum Wurzburg
RECRUITING
France Montpellier Cedex 5 CHU de Montpellier, Hopital Saint-Eloi
RECRUITING
France Nantes Cedex 1 CHU de Nantes hotel Dieu
RECRUITING
France Poitiers CHU Poitiers - Hopital la Miletrie
RECRUITING
France Toulouse Cedex 9 Institut Universitaire du Cancer Toulouse Oncopole
RECRUITING
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5

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