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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05338775
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research and Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research and Development LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries France, Germany, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsed/ Refractory Multiple Myeloma
Additional 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.

Arms & Interventions

Arms

Experimental: Part 1: Dose Escalation

Participants will receive either talquetamab (treatment regimen A) or teclistamab (treatment regimen B) with a PD-1 inhibitor biweekly.

Experimental: Part 2: Dose Expansion

Participants will receive either treatment regimen A or treatment regimen B with a PD-1 inhibitor at the dose levels identified in Part 1.

Interventions

Drug: - Talquetamab

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

Drug: - Teclistamab

Teclistamab will be administered as a SC injection.

Drug: - PD-1 Inhibitor

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Colorado Blood Cancer Institute, Denver, Colorado

Status

Recruiting

Address

Colorado Blood Cancer Institute

Denver, Colorado, 80218

New York, New York

Status

Recruiting

Address

The Blavatnik Family - Chelsea Medical Center at Mount Sinai

New York, New York, 10011

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Wake Forest Baptist Medical Center, Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157

Sarah Cannon Research Institute, Nashville, Tennessee

Status

Recruiting

Address

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Vanderbilt - Ingram Cancer Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, 37232

International Sites

CHU de Montpellier, Hopital Saint-Eloi, Montpellier Cedex 5, France

Status

Recruiting

Address

CHU de Montpellier, Hopital Saint-Eloi

Montpellier Cedex 5, , 34295

CHU de Nantes hotel Dieu, Nantes Cedex 1, France

Status

Recruiting

Address

CHU de Nantes hotel Dieu

Nantes Cedex 1, , 44093

CHU Poitiers - Hopital la Miletrie, Poitiers, France

Status

Recruiting

Address

CHU Poitiers - Hopital la Miletrie

Poitiers, , 86021

Toulouse Cedex 9, France

Status

Recruiting

Address

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse Cedex 9, , 31059

Dresden, Germany

Status

Recruiting

Address

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, , 01307

Universitaetsklinikum Hamburg Eppendorf, Hamburg, Germany

Status

Recruiting

Address

Universitaetsklinikum Hamburg Eppendorf

Hamburg, , 20246

Universitaetsklinikum Heidelberg, Heidelberg, Germany

Status

Recruiting

Address

Universitaetsklinikum Heidelberg

Heidelberg, , 69120

Universitatsklinikum Wurzburg, Wuerzburg, Germany

Status

Recruiting

Address

Universitatsklinikum Wurzburg

Wuerzburg, , 97080

Hosp. Univ. Germans Trias I Pujol, Badalona, Spain

Status

Recruiting

Address

Hosp. Univ. Germans Trias I Pujol

Badalona, , 08916

Hosp. Univ. Fund. Jimenez Diaz, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. Fund. Jimenez Diaz

Madrid, , 28040

Clinica Univ. de Navarra, Pamplona, Spain

Status

Recruiting

Address

Clinica Univ. de Navarra

Pamplona, , 31008

Hosp. Clinico Univ. de Salamanca, Salamanca, Spain

Status

Recruiting

Address

Hosp. Clinico Univ. de Salamanca

Salamanca, , 37007