Brief Summary
The purpose of this platform study is to assess the efficacy of teclistamab and talquetamab for patients who have functional high-risk disease, defined as relapsing or refractory within 18 months of first-line myeloma treatment. Patients who have functional high-risk disease currently do not have optimal treatments available via the Pharmaceutical Benefits Scheme and have poorer outcomes compared to myeloma patients who are not considered functional high-risk.
Intervention/Treatment
- Drug: Talquetamab
- Drug: Teclistamab
Inclusion Criteria:
- Age >= 18 years of age.
- Able to provide written consent.
- Documented diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of MM with measurable disease as define by any of the following
- Serum M-component greater than 5 g per L and/or
- Urine M-component greater than200 mg per 24 h, and/or
- Involved serum free light chain level greater than 100mg per L.
- Patients who do not meet these criteria but have biopsyremoval of a section of tissue to analyse for cancer cells proven extra-medullary disease (extra-osseous plasmacytoma that is not contiguous with an osseous plasmacytoma) that can undergo response evaluation with serial PET-CT are considered to have measurable disease.
- Documented evidence of progressive disease within 18 months of commencing front-line therapy for newly diagnosed MM according to IMWG response criteria
- Patients must have received only 1 prior therapy consisting of an IMID or PI-based induction regimen with or without high dosethe amount of medication taken melphalan conditioned autologous stem cell transplanta procedure that involves replacing unhealthy blood-forming cells (stem cells) with healthy stem cells +/- lenalidomide maintenance.
- No contraindication to the use of any of the study drugs and able to comply with trial requirements.
- Adequate liver function (total bilirubin less than 2.0x upper limit of normal (ULN), alanine aminotransferase less than 5.0x ULN) unless considered secondary to MM.
- Absolute neutrophil count greater than or equal to 1.0 x 10^9 per L. Granulocyte colony-stimulating factor (G-CSF) therapy is permitted on study.
- Platelet count greater than or equal to 50 x 10^9 per L (greater than or equal to 30 x 10^9 per L if MM involvement in the marrow is greater than 50 per cent), patients should not have received platelet transfusions within 7 days of the screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening platelet count.
- Hb greater than or equal to 80 g per L, red cell transfusions as per institutional protocol are allowed.
- Has provided written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..
- Women of childbearing potential participants must not become pregnant while on study; male participants must not father children while on study