AZD4045 for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AZD4045 for individuals with relapsed or refractory multiple myeloma (RRMM), a type of blood cancer. The study aims to assess the safety and effectiveness of AZD4045 both alone and in combination with other treatments like daratumumab and aldesleukin. It seeks participants who have previously tried at least three different treatment types and meet specific disease criteria, such as having certain protein levels in their blood or urine linked to multiple myeloma. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study tested AZD4045 for safety in patients with multiple myeloma. The results showed that AZD4045 is generally safe, with no reports of serious side effects like cytokine release syndrome (CRS) or nerve damage, which can sometimes occur with cancer treatments.
When combined with the drugs daratumumab and aldesleukin, AZD4045 maintained a safety profile similar to daratumumab used alone. Daratumumab is usually safe, but some patients might experience fatigue, nausea, or headaches. Serious reactions are rare but possible.
Overall, the research suggests that AZD4045, whether used alone or with daratumumab and aldesleukin, is safe for patients with relapsed or refractory multiple myeloma. However, individual experiences can differ, so discussing potential risks with a healthcare provider is important.12345Why are researchers excited about this trial's treatments?
Most treatments for multiple myeloma, such as proteasome inhibitors and immunomodulatory drugs, work by disrupting cancer cell growth and survival. However, AZD4045 is unique because it uses a novel mechanism to specifically target and disrupt pathways critical for myeloma cell survival. This targeted action could potentially improve effectiveness and reduce side effects compared to current therapies. Moreover, when combined with daratumumab and aldesleukin, AZD4045 might enhance immune response against the cancer, offering a potentially powerful new approach for patients. Researchers are excited about these possibilities because they represent a significant step forward in personalized cancer therapy.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research has shown that AZD4045 holds promise for treating multiple myeloma, a type of blood cancer. One study found that 96% of patients responded to AZD4045, with 85% achieving a complete response, meaning their cancer was not detectable. In this trial, participants may receive AZD4045 as a monotherapy or in combination with daratumumab and aldesleukin. Treatments with daratumumab have been shown to lower the risk of cancer progression and extend patient survival. These findings suggest that AZD4045, whether used alone or with other treatments, could be effective for people with multiple myeloma.46789
Are You a Good Fit for This Trial?
This trial is for adults with multiple myeloma that has come back or hasn't responded to previous treatments. Participants should be in generally stable health and able to attend regular clinic visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AZD4045 as a monotherapy and in association with daratumumab and aldesleukin
Follow-up
Participants are monitored for safety, efficacy, and cellular kinetics after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aldesleukin
- AZD4045
- Daratumumab
Trial Overview
The study is testing a new drug, AZD4045, alone and combined with daratumumab and aldesleukin, to see how safe it is and how well it works for people with relapsed or refractory multiple myeloma.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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
Clinical Outcomes of Daratumumab-Containing Regimens ...
Conclusions: Incorporating daratumumab into standard therapy for multiple myeloma significantly enhances progression-free survival and the rate of stringent ...
Daratumumab Plus Standard Therapy for Multiple Myeloma
Adding daratumumab to the standard treatment resulted in a nearly 60% drop in the risk of cancer progression or death (hazard ratio of 0.42), ...
3.
chi.scholasticahq.com
chi.scholasticahq.com/article/124362-daratumumab-based-therapeutic-approaches-and-clinical-outcomes-in-multiple-myeloma-and-other-plasma-cell-dyscrasias-insights-from-a-nationwide-real-wDaratumumab-Based Therapeutic Approaches and Clinical ...
Newly diagnosed and relapsed/refractory patients had an ORR of 92% and was 80.2%, and 61.4% patients achieved very good partial response or ...
DARZALEX® (daratumumab) Combination Regimens ...
At a median follow-up of 27.8 months, study results showed the addition of DARZALEX to VMP reduced the risk of disease progression or death by ...
AZD4045 - Multiple Myeloma Clinical Trials - SparkCures
The purpose of this study is to assess the safety, tolerability, preliminary efficacy, cellular kinetics, and other exploratory endpoints of AZD4045 as a ...
AZD4045 - Multiple Myeloma Clinical Trials
The purpose of this study is to assess the safety, tolerability, preliminary efficacy, cellular kinetics, and other exploratory endpoints of AZD4045 as a ...
7.
astrazeneca.com
astrazeneca.com/media-centre/press-releases/2024/astrazeneca-showcases-strength-of-haematology-portfolio-and-pipeline-at-ash-2024.htmlAstraZeneca showcases strength of haematology portfolio ...
Preliminary results from the ongoing investigator-initiated trial of AZD0120 suggest deep responses and an acceptable safety profile, with no ...
8.
bloodcancerstoday.com
bloodcancerstoday.com/post/azd0120-demonstrates-favorable-safety-profile-in-phase1b-trial-for-people-with-multiple-myelomaAZD0120 Demonstrates Favorable Safety Profile in ...
AZD0120 was well tolerated and patients experienced deep responses, well tolerated with no severe CRS or neurotoxicity
9.
ctv.veeva.com
ctv.veeva.com/study/a-modular-phase-i-ii-multicentre-study-to-evaluate-azd4045-in-participants-with-relapsed-or-refraA Modular, Phase I/II, Multicentre Study to Evaluate AZD4045 ...
The purpose of this study is to assess the safety, tolerability, preliminary efficacy, cellular kinetics, and other exploratory endpoints of ...
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