A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma
- Registration Number
- NCT05650632
- Lead Sponsor
- TeneoOne Inc.
- Brief 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 is broken into 2 Arms; Arm A (Parts 1 and 2) and Arm B. Arm A 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 (Dose A) will be used followed by the target dose A of ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. Around 120 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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).
- Arm A: Received BCMA-targeted therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm A (Part 2): ABBV-383 Dose Expansion ABBV-383 BCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles. Arm B: ABBV-383 BCMA Exposed ABBV-383 Participants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles. Arm C: ABBV-383 Step Up ABBV-383 Participants will receive step up dose and full target dose of ABBV-383 in 28 day cycles. Arm A (Part 1): ABBV-383 Dose Escalation ABBV-383 B-cell maturation antigen (BCMA) naïve participants will receive different doses of ABBV-383 in 28 day cycles.
- Primary Outcome Measures
Name Time Method Arm A (Part 1 and Part 2) and Arm C: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events Up to Day 28 CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines
Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS]) Up to Day 28 AEs of special interest will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) 2019 guidelines. All other AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
- Secondary Outcome Measures
Name Time Method Arm A and Arm C: Number of Cytokine Release Syndrome (CRS) Events Up to 3 Years CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines
Trial Locations
- Locations (41)
HCL - Hopital Lyon Sud /ID# 251223
🇫🇷Pierre Benite CEDEX, Rhone, France
Mayo Clinic Arizona /ID# 251405
🇺🇸Phoenix, Arizona, United States
Highlands Oncology Group - Springdale /ID# 267742
🇺🇸Springdale, Arkansas, United States
Rocky Mountain Cancer Centers - Aurora /ID# 268574
🇺🇸Aurora, Colorado, United States
Medical Oncology Hematology Consultants /ID# 268560
🇺🇸Newark, Delaware, United States
Hope And Healing Cancer Services /ID# 268536
🇺🇸Hinsdale, Illinois, United States
Fort Wayne Medical Oncology And Hematology /ID# 268179
🇺🇸Fort Wayne, Indiana, United States
Tulane University School of Medicine /ID# 251204
🇺🇸New Orleans, Louisiana, United States
Mayo Clinic - Rochester /ID# 251164
🇺🇸Rochester, Minnesota, United States
NHO Revive Research Institute, LLC /ID# 267869
🇺🇸Lincoln, Nebraska, United States
Mt Sinai /ID# 251166
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167
🇺🇸New York, New York, United States
University of North Carolina /ID# 251203
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest Univ HS /ID# 251165
🇺🇸Winston-Salem, North Carolina, United States
University Of Cincinnati Medical Center /ID# 251746
🇺🇸Cincinnati, Ohio, United States
Willamette Valley Cancer Institute and Research Center /ID# 267088
🇺🇸Eugene, Oregon, United States
Vanderbilt Ingram Cancer Center /ID# 252470
🇺🇸Nashville, Tennessee, United States
Texas Oncology - Central/South Texas /ID# 268563
🇺🇸Austin, Texas, United States
Oncology Consultants /ID# 268323
🇺🇸Houston, Texas, United States
Texas Oncology - Northeast Texas /ID# 268877
🇺🇸Tyler, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 268559
🇺🇸Fairfax, Virginia, United States
Fred Hutchinson Cancer Center /ID# 267940
🇺🇸Seattle, Washington, United States
Northwest Medical Specialties Tacoma /ID# 267117
🇺🇸Tacoma, Washington, United States
Juravinski Cancer Centre /ID# 252053
🇨🇦Hamilton, Ontario, Canada
Ottawa Hospital Research Institute /ID# 252151
🇨🇦Ottawa, Ontario, Canada
Odense University Hospital /ID# 251261
🇩🇰Odense, Syddanmark, Denmark
Sygehus Lillebalt, Vejle /ID# 251260
🇩🇰Vejle, Syddanmark, Denmark
Institut Paoli-Calmettes /ID# 252100
🇫🇷Marseille, Bouches-du-Rhone, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 252101
🇫🇷Creteil, Paris, France
CHU de Nantes, Hotel Dieu -HME /ID# 251196
🇫🇷Nantes, Pays-de-la-Loire, France
CHU Poitiers - La miletrie /ID# 251219
🇫🇷Poitiers, Vienne, France
AP-HP - Hopital Saint-Antoine /ID# 252326
🇫🇷Paris, France
The Chaim Sheba Medical Center /ID# 251329
🇮🇱Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 251573
🇮🇱Tel Aviv, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 252079
🇮🇱Jerusalem, Yerushalayim, Israel
Rabin Medical Center /ID# 251330
🇮🇱Petah Tikva, Israel
Hospital Universitario Marques de Valdecilla /ID# 251528
🇪🇸Santander, Cantabria, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 251545
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario de Salamanca /ID# 251529
🇪🇸Salamanca, Spain
University College London Hospital /ID# 251357
🇬🇧London, Greater London, United Kingdom
The Christie Hospital /ID# 251774
🇬🇧Manchester, United Kingdom