Investigating ABBV-383 for treating relapsed or refractory multiple myeloma
A Multicenter, Phase 1b, Open-label Study of ABBV-383 Administered Subcutaneously in Subjects With Relapsed or Refractory Multiple Myeloma
This study is testing a new drug called ABBV-383 to see if it can help adults with relapsed or refractory multiple myeloma feel better after trying other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 15 sites (Phoenix, Arizona and 14 other locations) |
| Trial ID | NCT06223516 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and pharmacokinetics of ABBV-383, an investigational drug, in adult participants with relapsed or refractory multiple myeloma. The trial is divided into three arms, where participants will receive ABBV-383 either as a subcutaneous injection or intravenous infusion. Approximately 55 adult participants will be enrolled across 25 sites globally, focusing on those who have undergone multiple prior treatments. The study aims to gather data on adverse events and clinical activity associated with ABBV-383.
Who should consider this trial
Good fit: Ideal candidates are adults with relapsed or refractory multiple myeloma who have received 3-5 prior lines of therapy and have not been treated with ABBV-383.
Not a fit: Patients who have previously received a BCMAxCD3 bispecific antibody will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat multiple myeloma.
How similar studies have performed: Other studies have shown promise with similar investigational drugs targeting multiple myeloma, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. * Participants with relapsed or refractory multiple myeloma who have received 3-5 prior lines of therapies and with prior triple class exposure including a proteasome inhibitor, anti-CD38 monoclonal antibody and an immunomodulatory drug. * Must be naïve to treatment with ABBV-383. Exclusion Criteria: - Received B-cell maturation antigen (BCMA)xCD3 bispecific antibody.
Where this trial is running
Phoenix, Arizona and 14 other locations
- Mayo Clinic Arizona /ID# 260799 — Phoenix, Arizona, United States (Recruiting)
- Mayo Clinic /ID# 262808 — Jacksonville, Florida, United States (Recruiting)
- Sylvester Comprehensive Cancer Center /ID# 260798 — Miami, Florida, United States (Recruiting)
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 261050 — Ann Arbor, Michigan, United States (Recruiting)
- Mayo Clinic - Rochester /ID# 262807 — Rochester, Minnesota, United States (Recruiting)
- Atrium Health Wake Forest Baptist Medical Center /ID# 260807 — Winston-Salem, North Carolina, United States (Recruiting)
- Wisconsin Medical Center /ID# 261085 — Milwaukee, Wisconsin, United States (Recruiting)
- Universitaetsklinikum Frankfurt /ID# 260442 — Frankfurt am Main, Hessen, Germany (Recruiting)
- Universitaetsklinikum Koeln /ID# 260445 — Köln, Nordrhein-Westfalen, Germany (Recruiting)
- Universitaetsklinikum Hamburg-Eppendorf /ID# 260444 — Hamburg, Germany (Recruiting)
- The Chaim Sheba Medical Center /ID# 261699 — Ramat Gan, Tel-Aviv, Israel (Recruiting)
- Tel Aviv Sourasky Medical Center /ID# 261525 — Tel Aviv, Tel-Aviv, Israel (Recruiting)
- Hadassah Medical Center-Hebrew University /ID# 261446 — Jerusalem, Yerushalayim, Israel (Recruiting)
- Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 265286 — Nagoya, Aichi, Japan (Recruiting)
- Kindai University Hospital /ID# 266016 — Osakasayama-shi, Osaka, Japan (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.