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
- Diseases
- Multiple myeloma
- 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
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Hosp. Univ. Germans Trias I Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hosp Univ Fund Jimenez Diaz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clinica Univ. de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hosp. Quiron Madrid Pozuelo Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Unknown status |
| Hosp Clinico Univ de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| VU Medisch Centrum Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| UMCU Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| University of Colorado Cancer Center Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Alabama Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Tennessee Oncology Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Mount SInai Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
Related publications
- Infections in MonumenTAL-1: a plain language summary of talquetamab treatment for relapsed/refractory multiple myeloma.Future Oncol · 2026 · PMID 42803498
- Talquetamab for people living with relapsed/ refractory multiple myeloma: plain language summary of the MonumenTAL-1 study.Future Oncol · 2026 · PMID 42669079
- Talquetamab in patients with relapsed/refractory multiple myeloma: 3-year follow-up of the phase 1/2 MonumenTAL-1 study.Blood · 2026 · PMID 42561120
- A plain language summary describing how talquetamab affects the way people with multiple myeloma feel and function in the MonumenTAL-1 study.Future Oncol · 2026 · PMID 42299486
This page is information, not medical advice. Discuss any trial with your doctor.