Relapsed Refractory Multiple Myeloma
Conditions
Interventions
- Biological: AZD0120
- Drug: Daratumumab
- Drug: Carfilzomib
- Drug: Dexamethasone
- Drug: Bortezomib
- Drug: Pomalidomide
Sponsors
Hibi Kazushige
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18 years or more - Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria - Documented evidence of measurable disease: 1. Serum M-protein level 1 g/dL or more 2. Urine M-protein level 200 mg/24h or more 3. Serum immunoglobulin free light chain 10 mg/dL (100 mg/L) or more and abnormal serum immunoglobulin kappa lambda free light chain ratio - Documented evidence of PD by IMWG 2016 criteria based on investigator's determination during or after the most recent line of therapy. Participants with only 1 prior line of therapy must have progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy - Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best response to the line of therapy - Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator. - ECOG performance status score of 0 to 1 - Adequate hematology and chemistry laboratory values: 1. Haemoglobin 8.0 g/dL or more 2. Absolute neutrophil count 1 x 10^9/L (1000 per mm3) or more 3. Platelet count 75 x 10^9/L (75000 per mm3) or more in participants with 50% less of bone marrow nucleated cells are plasma cells or 50 x 10^9/L (50000 per mm3) or more in participants with 50% or more of bone marrow nucleated cells are plasma cells 4. Absolute lymphocyte count 300/uL (0.3 x 10^9/L) or more 5. Total bilirubin 1.5 x ULN or more in the absence of Gilbert's syndrome or 3 x ULN or less if the participant has Gilbert's syndrome. AST and ALT 3.0 x ULN or more. CrCl by Cockcroft and Gault method 30 mL/minute or more.
Exclusion criteria
Exclusion criteria: - Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM. - Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome. - Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy) - Significant neurological or psychiatric condition - Significant medical condition that places the participant at an unacceptable risk for treatment -related complications - Previously received any prior BCMA-targeted treatment - Previously received CAR-T or CAR-NK therapy directed at any target - Previously received T-cell engager therapy directed at any target - Previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM. [Time Frame: 3 years] _ PFS: defined as time from randomisation until progression according to IMWG 2016 criteria as assessed by BICR, or death due to any cause, whichever occurs first. - To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of MRD negativity rate at 9 months in participants with RRMM. [Time Frame: 2 years] _ MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at 9 months (+- 3 months) from randomisation before initiation of subsequent anti-myeloma therapy. | — |
Countries
Australia, Brazil, Canada, France, Germany, Italy, Japan, Poland, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed