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.
Arm A: 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.
Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (anti-drug conjugate [ADC] or chimeric antigen receptor T-cell [CAR-T] directed against BCMA).

Exclusion Criteria:

- Arm A: Received BCMA-targeted therapy.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT05650632

Recruitment Status:

Recruiting

Sponsor:

TeneoOne Inc.

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There are 28 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
Mt Sinai /ID# 251166
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167
New York New York, 10065, United States
University of North Carolina /ID# 251203
Chapel Hill North Carolina, 27514, United States
Wake Forest Univ HS /ID# 251165
Winston-Salem North Carolina, 27157, United States
University of Cincinnati /ID# 251746
Cincinnati Ohio, 45267, United States
Vanderbilt Ingram Cancer Center /ID# 252470
Nashville Tennessee, 37232, United States
Juravinski Cancer Centre /ID# 252053
Hamilton Ontario, L8V 1, Canada
Ottawa Hospital Research Institute /ID# 252151
Ottawa Ontario, K1H 8, Canada
Odense Universitets Hospital /ID# 251261
Odense C Syddanmark, 5000, Denmark
Sygehus Lillebalt, Vejle /ID# 251260
Vejle Syddanmark, 7100, Denmark
Institut Paoli-Calmettes /ID# 252100
Marseille Bouches-du-Rhone, 13009, France
CHU de Nantes, Hotel Dieu -HME /ID# 251196
Nantes Pays-de-la-Loire, 44000, France
HCL - Hopital Lyon Sud /ID# 251223
Pierre Benite CEDEX Rhone, 69495, France
CHU Poitiers - La miletrie /ID# 251219
Poitiers Vienne, 86000, France
Hôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 252101
Créteil , 94010, France
AP-HP - Hopital Saint-Antoine /ID# 252326
Paris , 75012, France
Rabin Medical Center /ID# 251330
Haifa H_efa, 49414, Israel
The Chaim Sheba Medical Center /ID# 251329
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 251573
Tel Aviv Tel-Aviv, 64239, Israel
Hadassah Medical Center-Hebrew University /ID# 252079
Jerusalem Yerushalayim, 91120, Israel
Hospital Universitario Marques de Valdecilla /ID# 251528
Santander Cantabria, 39008, Spain
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 251545
Majadahonda Madrid, 28222, Spain
Hospital Universitario de Salamanca /ID# 251529
Salamanca , 37711, Spain
University College London Hospitals NHS Foundation Trust /ID# 251357
London , NW1 2, United Kingdom More Info
Site Coordinator
Contact
020 3447 2528
The Christie Hospital /ID# 251774
Manchester , M20 4, United Kingdom More Info
Site Coordinator
Contact
0161 446 3285

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT05650632

Recruitment Status:

Recruiting

Sponsor:


TeneoOne Inc.

How clear is this clinincal trial information?

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