Multiple Myeloma Clinical Trial

A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma

Summary

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM.

ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study includes 2 parts; step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 will be used followed by the target dose of ABBV-383. Around 80 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 30 sites across the world.

Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Must have measurable disease as outlined in the protocol.
Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
Relapsed/refractory (R/R) 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 International Myeloma Working Group (IMWG) 2016 criteria.
Must be naïve to treatment with ABBV-383.
Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.

Exclusion Criteria:

- Received B-cell maturation antigen (BCMA)-targeted therapy.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT05650632

Recruitment Status:

Recruiting

Sponsor:

TeneoOne Inc.

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There are 11 Locations for this study

See Locations Near You

Mayo Clinic Arizona /ID# 251405
Phoenix Arizona, 85054, United States
Tulane University /ID# 251204
New Orleans Louisiana, 70112, United States
Mayo Clinic - Rochester /ID# 251164
Rochester Minnesota, 55905, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167
New York New York, 10065, United States
Wake Forest Univ HS /ID# 251165
Winston-Salem North Carolina, 27157, United States
Vanderbilt Ingram Cancer Center /ID# 252470
Nashville Tennessee, 37232, United States
Juravinski Cancer Centre /ID# 252053
Hamilton Ontario, L8V 1, Canada
The Chaim Sheba Medical Center /ID# 251329
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 251573
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Hadassah Medical Center-Hebrew University /ID# 252079
Jerusalem Yerushalayim, 91120, Israel
Rabin Medical Center /ID# 251330
Petakh Tikva , 49414, Israel

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT05650632

Recruitment Status:

Recruiting

Sponsor:


TeneoOne Inc.

How clear is this clinincal trial information?

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