AZD0120 treatment for adults with newly diagnosed or early relapsed multiple myeloma.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, modular Phase 1 multicenter study testing AZD0120 in adults with newly diagnosed, early relapsed, or primary refractory multiple myeloma. The trial focuses primarily on safety and tolerability and also measures cellular kinetics, pharmacodynamics, immunogenicity, and preliminary efficacy. There are separate modules for newly diagnosed patients (including options with AZD0120 ± maintenance) and for patients with early relapsed or primary refractory disease after one or two prior therapies. Eligible participants must meet IMWG diagnostic criteria, have ECOG 0–1, and adequate organ and marrow function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Age:

* Males and females ≥18 years of age at the time of consent

Type of Participant and Disease Characteristics:

* Participant must have documented diagnosis of MM per IMWG diagnostic criteria
* ECOG performance status of 0 or 1.
* Adequate organ and bone marrow function.

For NDMM participants:

* Participants on Module 1: Newly diagnosed multiple myeloma (NDMM) without prior anti- myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable)
* For participants on Module 2: Newly diagnosed MM with a minimum of 4 cycles and a maximum of 6 cycles of induction therapy completed prior to screening
* Classified as high-risk MM

For Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) participants:

* Have received and failed 1 or 2 lines of anti-myeloma therapy
* Have received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) as part of their previous therapy
* Have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria within 1 year of starting treatment, or on or within 6 months of completing treatment of the subject's last line of anti-myeloma therapy, or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen

General Exclusion Criteria:

* Have received prior treatment with CAR T therapy directed at any target
* Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
* Active or history of plasma cell leukemia at the time of screening
* Seropositive for human immunodeficiency virus (HIV)
* Active Hepatitis B infection
* Active Hepatitis C infection
* Serious underlying medical condition

Where it's running

• Research Site
  Duarte, California, United States Recruiting
• Research Site
  Denver, Colorado, United States Recruiting
• Research Site
  Atlanta, Georgia, United States Recruiting
• Research Site
  Iowa City, Iowa, United States Recruiting
• Research Site
  St Louis, Missouri, United States Recruiting
• Research Site
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 6MW5311 in adults with relapsed or refractory blood cancers

  This study tests increasing doses of 6MW5311 in adults with multiple myeloma, AML, or CMML to see if it is safe and tolerable and to find a suitable dose for later studies.

  Recruiting Phase 1 Mabwell (Shanghai) Bioscience Co., Ltd. · Shanghai, Shanghai Municipality · NCT07914556

• Tailored exercise program to improve quality of life for adults with hematologic cancers

  This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.

  Recruiting Gruppo Italiano Malattie EMatologiche dell'Adulto · Roma, Rm and 2 other locations · NCT07912684

• Aspirin vs. rivaroxaban for blood clot prevention in newly diagnosed multiple myeloma

  In newly diagnosed multiple myeloma patients on IMiD-based therapy, this study tests whether aspirin or rivaroxaban is better at preventing blood clots.

  Recruiting Phase 4 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07907211

• Exercise phenotyping before chemotherapy in newly diagnosed multiple myeloma

  This observational study tests whether some newly diagnosed multiple myeloma patients with normal resting heart function already show limited exercise capacity, and whether that limitation relates to subtle heart tissue changes and future heart-related outcomes.

  Recruiting Technical University of Munich · Munich, Bavaria · NCT07851493

• SMS text check-ins to track symptoms for people with plasma cell disorders

  This study tests whether daily SMS symptom prompts are feasible and acceptable for adults starting treatment for multiple myeloma or AL amyloidosis.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07850284

• Cevostamab with Pomalidomide and Dexamethasone after BCMA-directed CAR T therapy in multiple myeloma

  This study tests if Cevostamab combined with pomalidomide and dexamethasone can help people with multiple myeloma who have already had CAR T therapy and several prior treatments.

  Recruiting at 5 sites Phase 2 Hoffmann-La Roche · Nuremberg, Bavaria and 4 other locations · NCT07825064

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.