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

Running, not enrolling · Phase 1

Conditions studied: Relapsed/ Refractory Multiple Myeloma

In brief

The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor.

Key facts

Study ID

NCT05338775

Run by

Janssen Research & Development, LLC

People needed

74

Starts

2022-05-25

Expected to finish

2027-05-03

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Colorado Blood Cancer Institute — Denver, Colorado, United States
• The Blavatnik Family Chelsea Medical Center at Mount Sinai — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
• CHU de Montpellier Hopital Saint Eloi — Montpellier, France
• CHU de Nantes hotel Dieu — Nantes, France
• CHU Poitiers - Hopital la Miletrie — Poitiers, France
• Institut Universitaire du Cancer Toulouse Oncopole — Toulouse, France
• Universitatsklinikum Carl Gustav Carus Dresden — Dresden, Germany
• Universitaetsklinikum Hamburg Eppendorf — Hamburg, Germany
• Universitaetsklinikum Heidelberg — Heidelberg, Germany
• Universitatsklinikum Wurzburg — Würzburg, Germany
• Hosp. Univ. Germans Trias I Pujol — Badalona, Spain
• Hosp Univ Fund Jimenez Diaz — Madrid, Spain
• Clinica Univ. de Navarra — Pamplona, Spain
• Hosp Clinico Univ de Salamanca — Salamanca, Spain

Full record on ClinicalTrials.gov

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