101 Participants NeededMy employer runs this trial

AZD4045 for Multiple Myeloma

Recruiting at 11 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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

I am 18 years old or older.
Participant must have screening bone marrow aspirate and/or archival sample adequate for clonal sequence calibration for MRD; archival sample from any time prior is acceptable
Participant must have documented evidence of PD by IMWG 2016 criteria based on Investigator's determination during or after the most recent line of therapy
See 5 more

Exclusion Criteria

Participant has known life-threatening allergy, hypersensitivity, intolerance, or contraindication to any study intervention or excipients
Concurrent enrolment in another clinical study unless observational or in follow-up period of interventional study
I had major surgery less than 28 days ago.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD4045 as a monotherapy and in association with daratumumab and aldesleukin

28 days

Follow-up

Participants are monitored for safety, efficacy, and cellular kinetics after treatment

Up to 2 years

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

Group I: Module 1: AZD4045 monotherapyExperimental Treatment1 Intervention
Group II: Module 1: AZD4045 in association with daratumumab and aldesleukinExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

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), ...

Daratumumab-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 ...

AstraZeneca 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 ...

AZD0120 Demonstrates Favorable Safety Profile in ...

AZD0120 was well tolerated and patients experienced deep responses, well tolerated with no severe CRS or neurotoxicity

A 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 ...