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NCT03145181Active, not recruitingPhase 1

Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

64007957MMY1001: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for Teclistamab and to characterize the safety and tolerability of Teclistamab at the RP2Ds.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
302 (actual)
First submitted
28 Apr 2017
Start date
16 May 2017
Primary completion date
25 Sept 2025
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT03145181
EU CT number
2023-503438-40-00
EudraCT number
2016-002122-36

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 302
  • From 16 May 2017 to the primary completion date, 25 Sept 2025
  • 27 sites in 8 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

  • Prior treatment with any B cell maturation antigen (BCMA) targeted therapy
  • Prior antitumor therapy as follows, before the first dose of study drug: Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less; Monoclonal antibody treatment for multiple myeloma within 21 days; Cytotoxic therapy within 21 days; Proteasome inhibitor therapy within 14 days; Immunomodulatory agent therapy within 7 days; Gene modified adoptive cell therapy (example, chimeric antigen receptor modified T cells, natural killer \[NK\] cells) within 3 months; Radiotherapy within 14 days or focal radiation within 7 days
  • Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
  • Received a cumulative dose of corticosteroids equivalent to \>= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)

Other

  • Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma

Who the study is looking for

  • Documented diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Measurable multiple myeloma that is relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory multiple myeloma or be intolerant of those established multiple myeloma therapies, and a candidate for Teclistamab treatment in the opinion of the treating physician. Prior lines of therapy must include a proteasome inhibitor, an immunomodulatory drug and anti-CD38 monoclonal antibody in any order during the course of treatment. Participants who could not tolerate a proteasome inhibitor or immunomodulatory drugs and an anti-CD38 monoclonal antibody are allowed
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Female participants of childbearing potential must use acceptable method of contraception
  • Participants must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease

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

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitair Ziekenhuis Gent
Coordinator of this site? Confirm its status
GentBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Universitaet Leipzig
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LeipzigGermanyCompleted
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyCompleted
Hospital Germans Trias i Pujol
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BadalonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Clínica Universidad de navarra
Coordinator of this site? Confirm its status
PamplonaSpainActive, not recruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceCompleted
Centre Hospitalier Universitaire de Nantes
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NantesFranceCompleted
Hospices Civils de Lyon
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Pierre-BéniteFranceCompleted
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceCompleted
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceCompleted
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceCompleted
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyCompleted
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyCompleted
Amsterdam UMC Stichting
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AmsterdamNetherlandsActive, not recruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenCompleted
Karolinska University Hospital
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HuddingeSwedenCompleted
Region Skane Skanes Universitetssjukhus
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LundSwedenCompleted
Levine Cancer Institute
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CharlotteUnited StatesUnknown status
Colorado Blood Cancer Institute
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DenverUnited StatesUnknown status
City of Hope
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DuarteUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
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New YorkUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status

Related publications

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