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Purpose

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd [daratumumab, carfilzomib, and dexamethasone], DPd [daratumumab, pomalidomide, and dexamethasone], PVd [pomalidomide, bortezomib and dexamethasone], or Kd [carfilzomib and dexamethasone]) in participants with RRMM.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years - Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria - Documented evidence of measurable disease: 1. Serum M-protein level ≥ 1 g/dL 2. Urine M-protein level ≥ 200 mg/24h 3. Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) 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 2. Absolute neutrophil count ≥ 1 × 10^9/L (1000 per mm3) 3. Platelet count ≥ 75 × 10^9/L (75000 per mm3) in participants with < 50% of bone marrow nucleated cells are plasma cells or ≥ 50 × 10^9/L (50000 per mm3) in participants with ≥ 50% of bone marrow nucleated cells are plasma cells 4. Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L) 5. Total bilirubin ≤ 1.5 × ULN in the absence of Gilbert's syndrome or ≤ 3 × ULN if the participant has Gilbert's syndrome. AST and ALT≤ 3.0 × ULN. CrCl by Cockcroft and Gault method ≥ 30 mL/minute

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Open-label
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A 		AZD0120
  • Biological: AZD0120
    CAR-T Cells
Active Comparator
Arm B 		1 of the following 4 standard regimens per investigator choice; DKd, DPd, PVd, Kd.
  • Drug: Daratumumab
    Daratumumab
    Other names:
    • Darzalex
  • Drug: Carfilzomib
    Carfilzomib
    Other names:
    • Kyprolis
  • Drug: Dexamethasone
    Dexamethasone
  • Drug: Bortezomib
    Bortezomib
    Other names:
    • Velcade
  • Drug: Pomalidomide
    Pomalidomides
    Other names:
    • Pomalyst and Imnovid

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.