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Clinical Trials in Germany / NCT05338775
Active, not recruiting Phase 1

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

NCT05338775 · tracked via the Priya Life Science Germany tracker
Phase
Phase 1
Started
2022-05-25
Last updated
2026-09-25

Condition(s) studied

Relapsed/ Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

Talquetamab →Teclistamab →PD-1 Inhibitor

Talquetamab: Talquetamab will be administered as a subcutaneous (SC) injection.

Teclistamab: Teclistamab will be administered as a SC injection.

PD-1 Inhibitor: The PD-1 inhibitor will be administered as an intravenous injection.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Colorado Blood Cancer Institute Denver Colorado
The Blavatnik Family Chelsea Medical Center at Mount Sinai New York New York
Icahn School of Medicine at Mount Sinai New York New York
Memorial Sloan Kettering Cancer Center New York New York
Wake Forest Baptist Medical Center Winston-Salem North Carolina
Sarah Cannon Research Institute Nashville Tennessee
Vanderbilt Ingram Cancer Center Nashville Tennessee
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

More Janssen Research & Development, LLC trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05338775 on ClinicalTrials.gov ↗ ← All trials in Germany