Intravenous ABBV-438 for relapsed/refractory 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 a Phase 1, open-label study that gives intravenous ABBV-438 alone to adults with relapsed/refractory multiple myeloma. The study has a dose-escalation phase to identify a recommended dose followed by a dose-expansion phase to confirm that dose. Safety, tolerability, adverse events, and pharmacokinetics (how the drug moves through the body) are the main outcomes. About 127 participants will be enrolled across roughly 24 sites worldwide.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Has relapsed or refractory Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the standard International Myeloma Working Group (IMWG) (2016) response criteria:

  * Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy;
  * Refractory defined as disease that is nonresponsive (failure to achieve minimal response) while on last therapy, or progresses within 60 days of last therapy.
* Has measurable disease at screening, defined by at least 1 of the following within 28 days prior to enrollment:

  * Serum M-protein \>= 0.5 g/dL (\>=5 g/L); OR;
  * Urine M-protein \>= 200 mg/24 hours; OR;
  * Involved serum free light chain (sFLC) \>= 10 mg/dL (100mg/L), provided serum FLC ratio is abnormal;
  * Must have had 3 or more prior lines of therapy with exposure to a proteasome inhibitor (PI), an immunomodulatory imide drugs (IMiD), and an anti-CD38 therapy and are intolerant to, or unable to access, available therapies that are known to confer clinical benefit to participants with relapsed or refractory (R/R) MM. Note: A line of therapy consists of relapsed or refractory 1 complete cycle of a single agent, a regimen consisting of a combination of several drugs, or a planned sequential therapy of various regimens.

Exclusion Criteria:

* Known history of Central Nervous System involvement by MM.
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.

Where it's running

• City of Hope National Medical Center /ID# 280273
  Duarte, California, United States Recruiting
• City of Hope - Orange County Lennar Foundation Cancer Center /ID# 279067
  Irvine, California, United States Recruiting
• Colorado Blood Cancer Institute /ID# 280275
  Denver, Colorado, United States Recruiting
• Moffitt Cancer Center /ID# 279068
  Tampa, Florida, United States Recruiting
• City Of Hope - Atlanta /ID# 280294
  Newnan, Georgia, United States Recruiting
• University of Chicago Medical Center /ID# 278863
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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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.