← Back to Search

Other

AZD0305 monotherapy for Multiple Myeloma

Phase 1 & 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Key

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of azd0305 to death (approximately 2 years)

Awards & highlights

Study Summary

This trial tests a new medicine for people with multiple myeloma to see if it's safe, works, and is tolerated.

Who is the study for?

This trial is for people with Multiple Myeloma who've had at least three prior treatments, including a proteasome inhibitor, an immunomodulator, and an anti-CD38 antibody. They should be relatively active (ECOG 0-1), expected to live at least six more months, and have certain levels of M protein or free light chains indicating disease presence.Check my eligibility

What is being tested?

The study tests AZD0305's safety and effectiveness in those whose multiple myeloma has returned or didn't respond to treatment. It's early-stage research involving multiple centers where participants openly receive the drug while researchers track its effects on their bodies and cancer.See study design

What are the potential side effects?

Specific side effects for AZD0305 aren't listed but may include typical reactions seen in cancer therapies such as nausea, fatigue, blood count changes, organ inflammation, allergic reactions to the drug components or increased susceptibility to infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

It seems there might be a mistake, as the term "Key" on its own is not a clear clinical trial exclusion criterion. If you could provide more information or context about this, I would be happy to help you further.

Select...

I am fully active or can carry out light work.

Select...

I have had 3 treatments including a proteasome inhibitor, an immunomodulator, and an anti-CD38 antibody.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of azd0305 to death (approximately 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of azd0305 to death (approximately 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of azd0305 to death (approximately 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only)

Secondary outcome measures

Phase Ia: Duration of response (DoR)

Phase Ia: Immunogenicity of AZD0305

Phase Ia: Objective Response Rate (ORR)

+17 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: AZD0305 monotherapyExperimental Treatment1 Intervention

Module 1: Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be prescribed at specified dose levels.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,272 Previous Clinical Trials

288,612,591 Total Patients Enrolled

7 Trials studying Multiple Myeloma

5,125 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there limitations to the number of subjects allowed in this trial?

"Correct. The clinicaltrials.gov database indicates that this medical trial is currently seeking patients, with 64 enrollees required for the experiment across 5 different sites. This project was first posted on December 5th 2023 and underwent its most recent update a few days later."

Answered by AI

Is this particular clinical trial still enrolling participants?

"Affirmative. According to clinicaltrials.gov, this research is currently recruiting participants; the study was posted on December 5th 2023 and last updated on December 14th of that same year. The trial requires 64 patients at five different sites for full participation."

Answered by AI

How many locations are currently conducting this trial?

"There are 5 centres presently accepting enrolment for this research project, located in Duarte, Irvine and Saint Louis among other cities. To minimize travel requirements, it is best to choose a site near you if you decide to join the trial."

Answered by AI

What goals is the research endeavor aiming to accomplish?

"According to the research sponsor, AstraZeneca, investigators will be assessing Phase II Objective Response Rate (ORR) over a period of 14 months. Other outcomes that this trial aims to measure are Progression free Survival (PFS), Minimal Residual Disease (MRD), and Duration of response (DoR)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma

2023. "AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06106945.