AZD0120: AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.
Daratumumab: Induction, optional bridging and continuous therapy.
Dexamethasone: Induction, optional bridging and continuous therapy.
Isatuximab: Induction, optional bridging and continuous therapy.
Lenalidomide: Induction, optional bridging and continuous therapy.
Bortezomib: Induction therapy.
Cyclophosphamide: Lymphodepletion
Fludarabine: Lymphodepletion
Study summary
This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of standard induction regimens (IsaVRd and DRd) followed by AZD0120 versus standard induction regimens followed by continuous therapy (IsaRd and DRd) in participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT) as initial therapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
INCLUSION CRITERIA:
1. Participants must be 18 years or older, at the time of signing the ICF.
2. Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria.
3. Participant must have one or more of the following measurable disease criteria: (a) Serum M-protein level ≥1.0 g/dL, (b) Urine M-protein level ≥ 200 mg/24 h, (c)Serum immunoglobulin FLC ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda FLC ratio.
4. Participant must be deemed ineligible for ASCT while also having adequate organ function for CAR-T cell treatment.
5. Participant is a candidate to receive at least one of the regimens (IsaVRd or DRd) as determined by the Investigator.
6. ECOG performance status Grade of 0 to 2.
7. Participant must have adequate organ and bone marrow function.
EXCLUSION CRITERIA:
1. Participant has active or prior CNS or meningeal involvement of MM.
2. Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome.
3. Participant has significant neurological or psychiatric condition posing risk or impairing evaluation.
4. Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation.
5. Participant has a history of a prior non-haematologic malignancy unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years.
6. Participant has a history of haematologic malignancies, other than MM, regardless of remission status.
7. Participant is positive for any of the following:
1. HIV: Known to be seropositive for HIV (including any history of HIV).
2. Chronic or active hepatitis B.
3. Active hepatitis C: Hepatitis C infection.
4. Additional local requirements for the testing for infectious diseases and exclusions of applicable participants should be followed per local regulations.
8. Participant has clinically significant cardiovascular disease.
9. Participant has COPD with an FEV1 \< 50% of predicted normal.
10. Additional exclusion for participants who are planned to receive IsaVRd as induction: Participant has peripheral neuropathy Grade 4, Grade 3, Grade 2, or Grade 1 with pain.
Primary outcome measure(s)
PFS in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd. — Up to 9 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.
MRD negative CR rate at 9M in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd — Up to 9 years. MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status (at threshold of 10-5) and have a response of CR or sCR (according to the IMWG 2016 criteria) as assessed by BICR at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.
Trial sites (124)
Facility
City
Region
Status
Research Site
Gilbert
Arizona
Not Yet Recruiting
Research Site
Phoenix
Arizona
Not Yet Recruiting
Research Site
Tucson
Arizona
Not Yet Recruiting
Research Site
Orange
California
Not Yet Recruiting
Research Site
Santa Monica
California
Not Yet Recruiting
Research Site
Aurora
Colorado
Not Yet Recruiting
Research Site
Denver
Colorado
Not Yet Recruiting
Research Site
New Haven
Connecticut
Not Yet Recruiting
Research Site
Coral Gables
Florida
Not Yet Recruiting
Research Site
Tampa
Florida
Not Yet Recruiting
Research Site
Atlanta
Georgia
Not Yet Recruiting
Research Site
Chicago
Illinois
Not Yet Recruiting
Research Site
Iowa City
Iowa
Not Yet Recruiting
Research Site
Wichita
Kansas
Not Yet Recruiting
Research Site
Louisville
Kentucky
Not Yet Recruiting
Research Site
Baton Rouge
Louisiana
Not Yet Recruiting
Research Site
Baltimore
Maryland
Not Yet Recruiting
Research Site
Detroit
Michigan
Not Yet Recruiting
Research Site
St Louis
Missouri
Not Yet Recruiting
Research Site
East Brunswick
New Jersey
Not Yet Recruiting
Research Site
Albany
New York
Not Yet Recruiting
Research Site
New Hyde Park
New York
Not Yet Recruiting
Research Site
New York
New York
Not Yet Recruiting
Research Site
New York
New York
Not Yet Recruiting
Research Site
New York
New York
Not Yet Recruiting
Research Site
The Bronx
New York
Not Yet Recruiting
Research Site
Chapel Hill
North Carolina
Not Yet Recruiting
Research Site
Charlotte
North Carolina
Not Yet Recruiting
Research Site
Durham
North Carolina
Not Yet Recruiting
Research Site
Winston-Salem
North Carolina
Not Yet Recruiting
Research Site
Winston-Salem
North Carolina
Not Yet Recruiting
Research Site
Cincinnati
Ohio
Not Yet Recruiting
Research Site
Cleveland
Ohio
Not Yet Recruiting
Research Site
Columbus
Ohio
Not Yet Recruiting
Research Site
Montgomery
Ohio
Not Yet Recruiting
Research Site
Portland
Oregon
Not Yet Recruiting
Research Site
Nashville
Tennessee
Not Yet Recruiting
Research Site
Nashville
Tennessee
Not Yet Recruiting
Research Site
Dallas
Texas
Not Yet Recruiting
Research Site
Houston
Texas
Not Yet Recruiting
+ 84 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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