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
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)
Number of Participants with Adverse Events (AEs) — Up to 2 years 5 months An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants with Adverse Events (AEs) by Severity — Up to 2 years 5 months An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Number of Participants with Abnormalities in Clinical Laboratory Assessments — Up to 2 years 5 months Number of participants with abnormalities in clinical laboratory assessments (serum chemistry and hematology) will be reported.
Number of Participants with Dose-Limiting Toxicity (DLTs) — Up to 2 years 5 months The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Trial sites (19)
Facility
City
Region
Status
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
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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.
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