A Phase 2 Clinical Trial of Teclistamab and Daratumumab in Previously Untreated AL Amyloidosis
Summary
The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis. The study treatment is divided into cycles (C) and each cycle is 28 days (D). Study treatment is expected to last 6 months.
Detailed description
The purpose of this study is to assess the effectiveness and safety of teclistamab-daratumumab combination in newly diagnosed AL amyloidosis. The study aims to evaluate whether this combination is able to effectively decrease the level of toxic amyloid-producing light chains circulating in the participants' blood, with the overarching goal of avoiding organ damage, improving organ function, and prolonging life.
Arms & interventions
- DrugTeclistamab
Teclistamab is a T-cell redirecting bispecific antibody (BsAb) targeting CD3 on T-cells and B-cell maturation antigen (BCMA) on plasma cells.
- DrugDaratumumab and Hyaluronidase-fihj
Daratumumab is an monoclonal antibody that targets the CD38 protein on the surface of myeloma cells.
Outcome measures
Primary
Hematologic Complete Response (Heme-CR) rate
Heme-CR will be defined as: involved free light-chain level less than the upper limit of the normal range with negative serum and urine immunofixation; normalization of the uninvolved free light-chain level or free light-chain ratio will not be required to determine a complete response.
Time frame: 6 months from treatment initiation
Secondary
Minimal Residual Disease (MRD) negativity rate by Free Light Chain Mass Spectrometry (FLC-MS) in serum
Time frame: 1 month, 3 months, 6 months, and 18 months
MRD-negativity rate by multiparameter flow cytometry (MFC) in bone marrow
Time frame: 6 months and 18 months
Time to heme-CR
Time frame: Day 1 of each cycle, and every 6 weeks after treatment cessation (up to 1 year)
Major organ deterioration-progression-free survival (MOD-PFS) rate
Time frame: From Cycle 2 to Cycle 6 Day 1 (Each cycle is 28 days), End of treatment visit (up to 6 months from treatment initiation), and up to 18 months from treatment initiation
Overall survival rate
Time frame: Through study completion, up to 18 months from treatment initiation
Frequency of Cytokine Release Syndrome (CRS)
Time frame: Throughout Cycle 1 (each cycle is 28 days), Day 0, Day 1, Day 3, Day 8, Day 15, Day 22; Throughout Cycle 2 and Cycle 6 on Day 1 and Day 15; End of treatment visit (up to 6 months from treatment initiation), Post treatment follow-up (up to 18 months)
Rate of infections
Time frame: Throughout Cycle 1 (each cycle is 28 days), Day 0, Day 1, Day 3, Day 8, Day 15, Day 22; Throughout Cycle 2 and Cycle 6 on Day 1 and Day 15; End of treatment visit (up to 6 months from treatment initiation), Post treatment follow-up (up to 18 months)
Number of participants with a heart response after treatment
Time frame: 6 months and 18 months
Number of No Responses in the heart after treatment
Time frame: 6 months and 18 months
Number of Partial Responses (PR) in participants who experienced a heart response after treatment
Time frame: 6 months and 18 months
Number of Very Good Partial Responses (VGPR) in participants who experienced a heart response after treatment
Time frame: 6 months and 18 months
Number of Complete Response (CR) in participants who experienced a heart response after treatment
Time frame: 6 months and 18 months
Number of participants with heart progression after treatment
Time frame: 6 months and 18 months
Number of participants with a kidney response after treatment
Time frame: 6 months and 18 months
Number of No Responses in the kidneys after treatment
Time frame: 6 months and 18 months
Number of Partial Responses (PR) in participants who experienced a kidney response after treatment
Time frame: 6 months and 18 months
Number of Very Good Partial Responses (VGPR) in participants who experienced a kidney response after treatment
Time frame: 6 months and 18 months
Number of Complete Response (CR) in participants who experienced a kidney response after treatment
Time frame: 6 months and 18 months
Number of participants with kidney progression after treatment
Time frame: 6 months and 18 months
Number of participants with liver response after treatment
Time frame: 6 months and 18 months
Number of No Responses in the liver after treatment
Time frame: 6 months and 18 months
Number of Partial Responses (PR) in participants who experienced liver response after treatment
Time frame: 6 months and 18 months
Number of Very Good Partial Responses (VGPR) in participants who experienced liver response after treatment
Time frame: 6 months and 18 months
Number of Complete Response (CR) in participants who experienced liver response after treatment
Time frame: 6 months and 18 months
Number of participants with liver progression after treatment
Time frame: 6 months and 18 months
Eligibility criteria
Study locations (1)
Columbia University Irving Medical Center
New York, New York, 10032