A Study of Talquetamab for People With Multiple Myeloma Who Have Received BCMA CAR T-Cell Therapy

NCT06066346 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 23-072
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 7

Brief Summary

The researchers are doing this study to find out whether talquetamab is an effective treatment after BCMA CAR Tcell therapy for people with relapsed or refractory multiple myeloma. All participants in this study will have already received the BCMA CAR T-cell therapy ide-cel for their disease.

Conditions

Multiple Myeloma

Keywords

Talquetamab; BCMA CAR T-Cell Therapy; 23-072

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.

  up to 2 years

Secondary Outcomes (1)

• Rate of sustained Minimal Residual Disease (MRD)

  2 years

Study Arms (1)

Talquetamab

EXPERIMENTAL

Subcutaneous Talquetamab

Drug: Talquetamab

Interventions

Talquetamab DRUG

Talquetamab will be administered SC until disease progression

Talquetamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with multiple myeloma who has received prior treatment with an IMID, PI, and a CD38 monoclonal antibody
• Received treatment with an FDA approved BCMA CART cell therapy ide-cel within 1-3 months prior to enrollment
• Serum monoclonal protein \< 0.5 gm/dL; 24-hour urine monoclonal protein \< 200 mg; and serum involved free light chains \< 10 mg/dL
• No evidence of disease progression based on IMWG criteria
• ≥18 years of age at the time of signing informed consent.
• ECOG performance status of 0 or 1
• Recovered to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding Grade 2 neuropathy and Grade 2 alopecia.
• No evidence of ongoing, any grade cytokine release syndrome or immune effector cell mediated neurotoxicity
• No additional myeloma therapies after the CART cell therapy
• Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 without growth factor support for 7 days for G-CSF or GM-CSF and for 14 days for pegylated GCSF prior to the laboratory test.
• Platelet count ≥ 75,000/mm\^3 (without platelet transfusion or thrombopoietin receptor agonist use in the previous 7 before the laboratory test). Platelets ≥ 50,000/mm\^3 is acceptable if the counts prior lymphodepleting chemotherapy for the preceding CAR T cell therapy was \< 75,000.
• Hemoglobin ≥ 8 g/dL (without red blood cell transfusion support or erythropoietin use within 7 days of the laboratory test).
• Creatinine Clearance (CrCl)/estimated glomerular filtration rate (eGFR) ≥ 30 mL/min, measured by 24 hour urine assessment or estimated by CKD-EPI2021.
• Oxygen saturation ≥ 92% on room air
• Hepatic Function:

You may not qualify if:

• Prior or concurrent exposure to any of the following in the specified time frame prior to enrollment:
• Received any prior GRPRC5D-directed therapy
• T-cell redirection therapy (for example, antibody therapy or BiTE's) within 3 months
• Investigational vaccine other than SARS CoV-2 vaccine approved/ in use under emergency approval within 4 weeks
• Live, attenuated vaccine within 4 weeks.
• Monoclonal antibody therapy within 21 days (with the exception of COVID monoclonal antibodies)
• Cytotoxic therapy within 21 days
• PI therapy within 14 days
• IMiD agent therapy within 14 days
• Radiotherapy within 14 days or focal radiation within 7 days
• Major surgery (as defined by the investigator) within 14 days
• Plasmapheresis within 14 days
• Received either of the following:
• An allogeneic SCT within 6 months before the first dose of study treatment. Participants who received an allogeneic transplant must be off all immunosuppressive medications during the 6 weeks before the start of study treatment administration without signs of graft-versus-host disease.
• An autologous SCT within 12 weeks before the start of study treatment administration

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Janssen Pharmaceuticals: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Multiple Myeloma

Interventions

talquetamab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sham Mailankody, MBBS

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sham Mailankody, MBBS

CONTACT

646-608-3712; mailanks@mskcc.org

Saad Usmani, MD, MBA

CONTACT

646-608-4165

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm phase II trial

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: September 27, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (7)