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NCT03399799Active, not recruitingPhase 1

Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

64407564MMY1001: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D 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 characterize the safety of Talquetamab and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for Talquetamab (Part 1 \[Dose Escalation\]) and to further characterize the safety of Talquetamab at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 \[Dose Expansion\]).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
279 (actual)
First submitted
22 Dec 2017
Start date
16 Dec 2017
Primary completion date
7 Jul 2022
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT03399799

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 279
  • From 16 Dec 2017 to the primary completion date, 7 Jul 2022
  • 13 sites in 4 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

  • Participants who received or plan to receive any live, attenuated vaccine within 4 weeks prior to the first dose, during treatment, or within 4 weeks of the last dose of Talquetamab. Non-live or non-replicating vaccines approved or authorized for emergency use (example, coronavirus disease \[COVID\]-19) by local health authorities are allowed
  • Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
  • Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( \>=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
  • An allogenic stem cell transplant within 6 months before first dose of study drug. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD); and/or an autologous stem cell transplant less than or equal to (\<=) 12 weeks before first dose of study drug

Other illness

  • Documented history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, whole body magnetic resonance imaging (MRI) and lumbar cytology are required

Who the study is looking for

  • Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Part 1: Participants with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies. Part 2: Participants with multiple myeloma measurable by central laboratory assessment who have progressed on, or could not tolerate, all available established therapies; Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=) 1.0 gram per deciliter (g/dL) or urine M-protein level \>=200 milligram per 24 hours (mg/24 h) or light chain multiple myeloma without measurable disease in the serum or the urine: serum immunoglobulin free light chain (FLC) \>= 10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio; If central laboratory assessments are not available, relevant local laboratory measurements must exceed the minimum required level by at least 25%
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin \[beta-hCG\]) or urine
  • Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able 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 (13)

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

SiteCityCountrySite status
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Coordinator of this site? Confirm its status
LiègeBelgiumUnknown status
Hosp. Univ. Germans Trias I Pujol
Coordinator of this site? Confirm its status
BadalonaSpainUnknown status
Hosp Univ Fund Jimenez Diaz
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MadridSpainUnknown status
Clinica Univ. de Navarra
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PamplonaSpainUnknown status
Hosp. Quiron Madrid Pozuelo
Coordinator of this site? Confirm its status
Pozuelo de AlarcónSpainUnknown status
Hosp Clinico Univ de Salamanca
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SalamancaSpainUnknown status
VU Medisch Centrum
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AmsterdamNetherlandsUnknown status
UMCU
Coordinator of this site? Confirm its status
UtrechtNetherlandsUnknown status
University of Colorado Cancer Center
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AuroraUnited StatesUnknown status
University of Alabama Birmingham
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BirminghamUnited StatesUnknown status
City of Hope
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DuarteUnited StatesUnknown status
Tennessee Oncology
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NashvilleUnited StatesUnknown status
Mount SInai Medical Center
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New YorkUnited StatesUnknown status

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