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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05338775
Other study ID # CR109168
Secondary ID 2021-005073-2264
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 25, 2022
Est. completion date November 28, 2025

Study information

Verified date June 2024
Source Janssen Research & Development, LLC
Contact Study Contact
Phone 844-434-4210
Email Participate-In-This-Study@its.jnj.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 152
Est. completion date November 28, 2025
Est. primary completion date September 21, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
France CHU de Montpellier, Hopital Saint-Eloi Montpellier Cedex 5
France CHU de Nantes hotel Dieu Nantes Cedex 1
France CHU Poitiers - Hopital la Miletrie Poitiers
France Institut Universitaire du Cancer Toulouse Oncopole Toulouse Cedex 9
Germany Universitatsklinikum Carl Gustav Carus Dresden Dresden
Germany Universitaetsklinikum Hamburg Eppendorf Hamburg
Germany Universitaetsklinikum Heidelberg Heidelberg
Germany Universitatsklinikum Wurzburg Wuerzburg
Spain 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
United States Colorado Blood Cancer Institute Denver Colorado
United States Sarah Cannon Research Institute Nashville Tennessee
United States Vanderbilt - Ingram Cancer Center Nashville Tennessee
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 The Blavatnik Family Chelsea Medical Center at Mount Sinai New York New York
United States Wake Forest Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  France,  Germany,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events (AEs) 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. Up to 2 years 5 months
Primary Number of Participants with Adverse Events (AEs) by Severity 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. Up to 2 years 5 months
Primary Number of Participants with Abnormalities in Clinical Laboratory Assessments Number of participants with abnormalities in clinical laboratory assessments (serum chemistry and hematology) will be reported. Up to 2 years 5 months
Primary Number of Participants with Dose-Limiting Toxicity (DLTs) The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. Up to 2 years 5 months
Secondary Overall Response Rate (ORR) ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria. Up to 2 years 5 months
Secondary Very Good Partial Response (VGPR) or Better Response Rate VGPR or better response rate is defined as the percentage of participants who achieve a VGPR or better response (stringent complete response [sCR]+ complete response [CR]+VGPR) according to the IMWG 2016 criteria. Up to 2 years 5 months
Secondary Complete Response (CR) or Better Response Rate CR or better response rate is defined as the percentage of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria. Up to 2 years 5 months
Secondary Stringent Complete Response (sCR) Rate sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria. Up to 2 years 5 months
Secondary Duration of Response Duration of response is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG 2016 criteria or death due to any cause, whichever occurs first. Up to 2 years 5 months
Secondary Time to Response Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better. Up to 2 years 5 months
Secondary Serum Concentrations of Talquetamab Serum samples will be analyzed to determine concentrations of Talquetamab using validated, specific, and sensitive immunoassay methods. Up to 2 years 5 months
Secondary Serum Concentrations of Teclistamab Serum samples will be analyzed to determine concentrations of Teclistamab using validated, specific, and sensitive immunoassay methods. Up to 2 years 5 months
Secondary Serum Concentrations of PD-1 Inhibitor Serum samples will be analyzed to determine concentrations of PD-1 inhibitor using validated, specific, and sensitive immunoassay methods. Up to 2 years 5 months
Secondary Number of Participants with Anti-Talquetamab Antibodies Number of participants with anti-talquetamab antibodies will be reported. Up to 2 years 5 months
Secondary Number of Participants with Anti-Teclistamab Antibodies Number of participants with anti-teclistamab antibodies will be reported. Up to 2 years 5 months
Secondary Number of Participants with Anti-PD-1 Inhibitor Antibodies Number of participants with anti-PD-1 inhibitor antibodies will be reported. Up to 2 years 5 months
See also
  Status Clinical Trial Phase
Withdrawn NCT05461209 - A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma Phase 3
Terminated NCT03445663 - Study Evaluating AMG 424 in Subjects With Multiple Myeloma Phase 1
Recruiting NCT05850234 - A Study of GC012F, a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma Phase 1/Phase 2