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NCT04586426Active, not recruitingPhase 1/2

A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 1b/2 Dose Escalation and Expansion Study of the Combination of the Bispecific T Cell Redirection Antibodies Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 16 Jan 2026

Brief summary (registry, in English)

The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R\[s\]) and schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab + teclistamab in participants with relapsed or refractory multiple myeloma and extramedullary disease (EMD) (Part 3).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
228 (actual)
First submitted
12 Oct 2020
Start date
15 Dec 2020
Primary completion date
18 Mar 2025
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT04586426
EU CT number
2023-503439-16-00
EudraCT number
2019-004124-38

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 228
  • From 15 Dec 2020 to the primary completion date, 18 Mar 2025
  • 39 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • All Parts: Targeted therapy, epigenetic therapy, or treatment with an investigational treatment or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less. Part 3: prior BCMA targeted bispecific antibody therapy; prior GPRC5D targeted therapy
  • All Parts: Allogeneic stem cell transplant within 6 months before the first dose of study treatment.

Other illness

  • All Parts: Active plasma cell leukemia (greater than \[\>\]2.0\*10\^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M- protein, and skin changes), or primary amyloid light chain amyloidosis

Other

  • All Parts: Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma.

Who the study is looking for

  • Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Part 1 and 2: Participant could not tolerate or has disease that is relapsed or refractory to established therapies, including the last line of therapy. Part 3: (a) Relapsed or refractory disease, and exposed to a PI, IMiD, and an anti-CD38 mAb; (b) Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
  • Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration. Part 3: ECOG performance status grade of 0, 1, or 2 at screening and immediately before the start of study drug administration

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (39)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
St Vincents Hospital Melbourne
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FitzroyAustraliaUnknown status
Royal Perth Hospital
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PerthAustraliaUnknown status
Arthur J.E. Child Comprehensive Cancer Centre
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CalgaryCanadaUnknown status
Alberta Health Services
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EdmontonCanadaUnknown status
McGill University Health Centre
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MontrealCanadaUnknown status
Princess Margaret Cancer Centre - University Health Network
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TorontoCanadaUnknown status
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
Hadassah medical Center
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JerusalemIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Kanazawa University Hospital
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KanazawaJapanUnknown status
Nagoya City University Hospital
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NagoyaJapanUnknown status
Osaka University Hospital
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OsakaJapanUnknown status
Tohoku University Hospital
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SendaiJapanUnknown status
Japanese Red Cross Medical Center
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Shibuya CityJapanUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaUnknown status
Emory University
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AtlantaUnited StatesUnknown status
University of Alabama at Birmingham, Comprehensive Cancer Center
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BirminghamUnited StatesUnknown status
Atrium Health
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CharlotteUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
Colorado Blood Cancer Institute
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DenverUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
University of Arkansas for Medical Sciences
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Little RockUnited StatesUnknown status
Mount SInai Medical Center
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
Washington University St. Louis School Medicine Siteman Cancer Center
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St LouisUnited StatesUnknown status
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
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Winston-SalemUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.