Talquetamab Consolidation After BCMA CART Cell Therapy for Relapsed or Refractory Multiple Myeloma

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)

⁃ Serum total bilirubin ≤ 2 x ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤1.5 x ULN is required).

• International ratio (INR) or partial thromboplastin time (PTT) \< 1.5 x ULN

• Cardiac Function: left ventricular ejection fraction ≥ 45% by echocardiogram (ECHO) or multigated acquisition scan (MUGA).

• Willing and able to adhere to the study visit schedule and other protocol requirements

• Female patients of childbearing potential (FCBP) must:

‣ Have a negative highly-sensitive serum β-human chorionic gonadotropin (β-hCG) pregnancy test (\<5 IU/mL) at screening and a negative urine or serum pregnancy test within 24 hours before the first dose of study drug.

⁃ Practicing a highly effective, preferably user-independent method of contraception (failure rate of \<1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study drug and until 100 days after last dose.

⁃ Agree to pregnancy testing (serum or urine) within 100 days after the last study drug administration.

⁃ Agree to use an additional contraceptive method in addition to the requirements listed above

⁃ Agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 100 days after the last dose of study drug.

⁃ Agree to abstain from breastfeeding from screening through at least 6 months after the last dose of talquetamab

• Male patients must:

‣ Agree to wear a condom when engaging in any activity that allows for passage of ejaculate to another person, during the study and for 100 days after the last dose of study drug. Male subjects should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak.

⁃ Men must agree not to donate sperm for the purpose of reproduction during the study and for at least 100 days after receiving the last dose of study drug.

• Must sign an ICF (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITING
Uniondale
Contact Information
Primary
Sham Mailankody, MBBS
mailanks@mskcc.org
646-608-3712
Backup
Saad Usmani, MD, MBA
646-608-4165
Time Frame
Start Date: 2023-09-27
Estimated Completion Date: 2026-10
Participants
Target number of participants: 17
Treatments
Experimental: Talquetamab
Subcutaneous Talquetamab
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center
Collaborators: Janssen Pharmaceuticals

This content was sourced from clinicaltrials.gov