Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
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:
Male patients must:
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.
Exclusion criteria
Prior or concurrent exposure to any of the following in the specified time frame prior to enrollment:
Received either of the following:
A maximum cumulative dose of corticosteroids of ≥ 140 mg of prednisone or equivalent within 14-day period before the first dose of study drug (does not include pretreatment medications).
Prior organ transplant requiring systemic immunosuppressive therapy
History of ≥ Grade 2 hemorrhage within 30 days of enrollment
Patient requiring ongoing treatment with chronic, therapeutic dosing of anticoagulants (e.g., Warfarin, low molecular weight heparin, Factor Xa inhibitors) can be enrolled with approval of the PI.
History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Additionally, any patients with meningeal or CNS involvement of MM will be excluded.
Having concurrent Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), active plasma cell leukemia, or clinically significant amyloidosis
History of Class III or IV congestive heart failure (CHF) or severe nonischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or hemodynamically significant ventricular arrhythmia within the previous 6 months prior to enrollment
Active clinically significant autoimmune disease, defined as a history of requiring systemic immunosuppressive therapy and at ongoing risk for potential disease exacerbation. Patients with a history of autoimmune thyroid disease, asthma, or limited skin manifestations are potentially eligible. Patients with a history of acute or chronic GVHD are potentially eligible if on minimal immunosuppressants as defined previously.
Seropositive for human immunodeficiency virus (HIV-1). Acute hepatitis A. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative with antibodies to total hepatitis B core antigen [Anti-HBc] with or without the presence of hepatitis B surface antibodies [Anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of HBVDNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (Anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR. Active hepatitis C infection as measured by positive hepatitis C virus (HCV)-RNA testing. Subjects with a history of Hepatitis C virus antibody positivity must undergo HCV-RNA testing
Prior malignancies except resected basal cell carcinoma or treated carcinoma in situ. Cancer treated with curative intent less than 5 years prior to enrollment will not be allowed unless approved by the PI. Cancer treated with curative intent greater than 5 years prior to enrollment is allowed.
Myelodysplastic syndrome or active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than relapsed/refractory multiple myeloma. The only allowed exceptions are:
Female patients who are breastfeeding or who intend to become pregnant during participation in the study or until 100 days after the last dose of therapy.
Participant plans to father a child while enrolled in this study or within 100 days after the last dose of study treatment.
Known allergy or hypersensitivity to any of the study medications, their analogues, or excipients in the various formulations of any agent.
Serious medical of psychiatric illness likely to interfere with participation on this clinical study
Uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.
Acute diffuse infiltrative pulmonary disease requiring home oxygen therapy
Unwilling or unable to provide informed consent
Unable or unwilling to return to the center for treatment and follow up
Primary purpose
Allocation
Interventional model
Masking
17 participants in 1 patient group
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Central trial contact
Sham Mailankody, MBBS; Saad Usmani, MD, MBA
Data sourced from clinicaltrials.gov
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