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Sponsor: AstraZeneca
Conditions: Newly Diagnosed Multiple Myeloma (NDMM)
Interventions: AZD0120, Cyclophosphamide, Fludarabine, Melphalan (part of ASCT), Lenalidomide
Countries: United States, Australia, Brazil, Canada, Denmark, France, Germany, Italy
The purpose of this study is to measure the efficacy of AZD0120 compared with ASCT in terms of progression-free survival (PFS) according to the International Myeloma Working Group (IMWG) criteria 2016, and MRD negative complete response (CR) rate at 9 months as assessed by Blinded Independent Central Review (BICR), in participants with TE NDMM. Study details include: * The study duration is estimated to be up to 13 years from the date the first participant is randomised. * For participants in Arm A (AZD0120), the total duration of participant follow-up will be 15 years (including a Long Term Follow-up study) after the last participant has received the AZD0120 infusion. * The treatment duration will be:- Arm A (AZD0120): lymphodepletion over 3 days, a single-day infusion of AZD0120, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment. * Arm B (ASCT): conditioning therapy over 24 to 48 hours, ASCT, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment. Disclosure Statement: This is an open-label, randomised study with 2 treatment arms.
Sex: ALL
Age: 18 Years to 130 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * ≥18 years of age. * Documented diagnosis of NDMM according to IMWG diagnostic criteria. * Documented measurable disease at diagnosis (serum M-protein ≥ 1.0 g/dL, urine M-protein 200 mg/24 hour, or serum Ig FLC 10 mg/dL (100 mg/L) and abnormal serum Ig kappa lambda FLC ratio) * Must have completed 4 to 6 cycles of induction therapy with any of the following approved regimens: anti-CD38+VRd, DVTd, DRd or VRd * Participant must have at least SD or better per IMWG response criteria (2016) after completion of induction, and prior to randomisation. * ECOG performance status score of 0 or 1. * Eligible for treatment with high-dose melphalan (200 mg/m²) followed by ASCT. * Adequate organ and bone marrow function. 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 (at diagnosis and/or at time of screening), Waldenstrom macroglobulinemia or POEMS syndrome. * Significant neurological or psychiatric condition * Significant medical condition that places the participant at an unacceptable risk for treatment-related complications * Participants who required the introduction of an additional agent therapy due to inadequate response. * Prior T-cell engager therapy directed at any target. * Prior CAR-T and/or CAR-NK cell therapy directed at any target for any indications * Prior any therapy that is targeted to BCMA and CD19.
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- Cleveland, Ohio, United States
- San Antonio, Texas, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
- Brisbane, Australia
- Camperdown, Australia
- Darlinghurst, Australia
- Fitzroy, Australia
- Melbourne, Australia
- Nedlands, Australia
- Salvador, Brazil
- São Paulo, Brazil
- São Paulo, Brazil
- Calgary, Alberta, Canada
- Aarhus, Denmark
- København Ø, Denmark
- Odense, Denmark
- Lille, France
- Nantes, France
- Paris, France
- Paris, France
- Toulouse, France
- Berlin, Germany
- Dresden, Germany
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