Phase 2 study for people with Myeloma

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor AstraZeneca
Registry number NCT06106945
Started 5 December 2023 Today 16 October 2026 Estimated completion 16 August 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Research Site Fitzroy Australia Recruiting
Research Site Melbourne VIC Recruiting
Research Site Nedlands WA Recruiting
Research Site Wollongong NSW Not yet recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 226

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Key Inclusion Criteria:

* Participants must be at least 18 years of age or the legal age of consent in the jurisdiction

* in which the study is taking place;

* Eastern Cooperative Oncology Group performance status of ≤ 2 in module 1, or 0 or 1 in modules 2 and 3;

* Documentation of Multiple Myeloma (MM) as defined by International Myeloma Working Group (IMWG) Diagnostic Criteria for Multiple Myeloma. Site should ensure that Multiple Myeloma diagnosis is confirmed in accordance with the IMWG Diagnostic Criteria;

* Participants must have one or more measurable disease criteria for Serum M-Protein, Urine M-protein, and Serum immunoglobulin free light chains as specified in the relevant module of the CSP;

* Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP as relevant to each module;

* Participants must have received at least 3 prior lines of treatment in module 1, or 1-3 prior lines in modules 2 and 3, with additional module-specific requirements related to prior lines of therapy

The above is a summary of key criteria, other inclusion criteria details may apply

Key Exclusion Criteria:

* Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or Smoldering Multiple Myeloma (compliant with WHO criteria);

* Participants exhibiting clinical signs of central nervous system involvement of MM;

* Participants with known COPD, or previous history of ILD/pneumonitis;

* Participants with known moderate or severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification;

* Participants who have severe cardiovascular disease which is not adequately controlled;

* Participants who have a history of immunodeficiency disease;

* Participants with peripheral neuropathy ≥ Grade 2;

* Primary refractory MM;

* Participants who have previously received anti-GPRC5D or MMAE-containing treatment;

* Participants who have previously received allogenic stem cell transplant, or participant has received autologous stem cell transplant within 3 months before the first dose of study intervention;

* Participants with a history of prior malignancy other than MM within 3 years prior to first dose of study intervention. some exceptions apply;

* Participants with previous history of active JC virus infection resulting in PML;

* Participants with a known hypersensitivity to AZD0305 or any of the excipients of the product or to any of the drugs included in the respective modules or who experienced Grade 3 or higher hypersensitivity to prior monoclonal antibody therapy;

* Participants who have uncontrolled severe illness including but not limited to ongoing active infection requiring therapeutic antibiotics and/or other administration

The above is a summary of key criteria, other exclusion criteria details may apply

Dates on the record

Started 5 December 2023
Estimated completion 16 August 2027
Registry last updated 19 August 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 19 August 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.