AZD0120 vs ASCT for Multiple Myeloma
(DURGA-6 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatments for individuals with newly diagnosed multiple myeloma, a type of blood cancer. One group will receive an experimental CAR-T cell therapy called AZD0120, while the other will undergo a standard procedure known as autologous stem cell transplant (ASCT). The researchers aim to determine which treatment helps patients live longer without cancer progression. Participants must have multiple myeloma, have completed several cycles of initial treatment, and be in stable condition. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AZD0120, a therapy using modified immune cells, is generally well tolerated. A previous study found that serious side effects occurred rarely among patients. Notably, no severe immune reactions or brain-related side effects were reported. These findings suggest that AZD0120 is likely safe.
In contrast, Autologous Stem Cell Transplant (ASCT) is a well-established treatment for multiple myeloma. It involves administering high-dose chemotherapy followed by a stem cell transplant. While effective, ASCT can cause side effects such as infections, fatigue, and bleeding due to low blood cell counts.
Both treatments are being compared for efficacy and safety, but current evidence supports AZD0120 as a well-tolerated option.12345Why do researchers think this study treatment might be promising for multiple myeloma?
Unlike the standard of care for multiple myeloma, which often includes autologous stem cell transplant (ASCT) and chemotherapy, AZD0120 is a cutting-edge CAR-T therapy. This treatment involves engineering a patient's own T-cells to better recognize and attack cancer cells, offering a personalized approach to combat the disease. Researchers are excited because AZD0120 has the potential to provide a more targeted and effective treatment by harnessing the body's immune system, which could lead to improved outcomes and potentially fewer side effects compared to traditional treatments.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
This trial will compare AZD0120, a type of CAR-T therapy, with Autologous Stem Cell Transplant (ASCT) for treating multiple myeloma. Research has shown that AZD0120 could be promising for this condition. CAR-T therapies modify a patient's immune cells to enhance their ability to fight cancer. Early signs suggest these therapies can lead to long-lasting improvements, especially in patients with difficult-to-treat cancer. While specific results for AZD0120 in multiple myeloma are still under investigation, similar therapies have demonstrated significant benefits, such as longer periods without cancer growth and higher rates of complete recovery. This suggests that AZD0120 might be effective for multiple myeloma patients.678910
Are You a Good Fit for This Trial?
This trial is for adults with newly diagnosed multiple myeloma who are eligible for a stem cell transplant. Participants should be healthy enough to undergo intensive treatment and meet specific medical requirements set by the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants in Arm A receive lymphodepletion over 3 days, a single-day infusion of AZD0120, followed by up to 2 years of lenalidomide monotherapy maintenance treatment. Participants in Arm B receive conditioning therapy over 24 to 48 hours, ASCT, followed by up to 2 years of lenalidomide monotherapy maintenance treatment.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a focus on progression-free survival and other outcomes.
Long Term Follow-up
For participants in Arm A, a long-term follow-up study is conducted for 15 years after the last AZD0120 infusion.
What Are the Treatments Tested in This Trial?
Interventions
- AZD0120
- Cyclophosphamide
- Fludarabine
- Lenalidomide
- Melphalan
Trial Overview
The study compares two treatments after initial therapy: one group receives an experimental drug called AZD0120, while the other gets standard high-dose chemotherapy followed by a stem cell transplant (ASCT). Both groups may get lenalidomide as maintenance therapy afterward.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
AZD0120 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy.
ASCT: High-dose melphalan followed by autologous stem cell rescue
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Citations
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DURGA-1 - Multiple Myeloma Clinical Trials - SparkCures
Preliminary phase 1b results demonstrated AZD0120 was well tolerated, with a low incidence of serious AEs, no grade ≥3 CRS, and no ICANS.
AZD0120 in Relapsed/Refractory Multiple Myeloma ...
Participant has a history of significant toxicity during prior CAR T-cell therapy and T-cell engaging therapy. Participant has significant cardiac, ...
A Phase I, Open-label, Multicenter Study to Evaluate ...
This is an interventional, modular, center study to primarily evaluate the safety and tolerability of AZD0120 in adult participants
AZD0120 in Relapsed/Refractory Multiple Myeloma ...
Phase 1b aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, and immunogenicity in subjects with relapsed/ ...
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yalemedicine.org
yalemedicine.org/clinical-trials/durga-4-a-phase-iii-open-label-randomised-multicentre-study-to-evaluate-azd0120-in-participantsA Phase III Open-label, Randomised, Multicentre Study ...
This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard ...
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