A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma
Launched by TENEOONE INC. · Dec 6, 2022
Trial Information
Current as of January 17, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called ABBV-383 for adults with relapsed or refractory multiple myeloma, a type of blood cancer. Multiple myeloma occurs when plasma cells in the blood grow uncontrollably, often causing problems like bone pain and infections. The trial will look at how safe ABBV-383 is and whether it helps improve symptoms in patients whose cancer has returned or hasn’t responded well to previous treatments. About 180 adults will participate, and they will receive the medication as an infusion into a vein over 28-day cycles for up to three years.
To be eligible for the trial, participants must have measurable disease and have already received multiple lines of treatment for their cancer. Depending on the specific group they join in the study, there are different requirements regarding past therapies they must have received. Participants can expect regular hospital visits for assessments, blood tests, and to monitor for any side effects during the trial. It's important to note that this trial might involve a more intensive treatment schedule than standard care, but it aims to explore a promising new option for those with challenging cases of multiple myeloma.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Must have measurable disease as outlined in the protocol.
- • Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. Arm C only: ECOG performance of \<= 1.
- • 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 (must be an anti-drug conjugate \[ADC\] or chimeric antigen receptor T-cell \[CAR-T\] directed against BCMA).
- • Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of ABBV-383.
- Exclusion Criteria:
- • Arm A: Received BCMA-targeted therapy.
- • Arm C: Rapidly progressing disease per investigator.
Trial Officials
TeneoOne Inc
Study Director
TeneoOne Inc.
About Teneoone Inc.
TeneoOne Inc. is a clinical stage biopharmaceutical company dedicated to advancing innovative therapies for the treatment of cancer. Focused on harnessing the power of the immune system, TeneoOne is committed to developing novel agents that aim to enhance patient outcomes and improve quality of life. With a robust pipeline and a team of experienced professionals, TeneoOne leverages cutting-edge science and strategic collaborations to drive its clinical programs forward, striving to make a meaningful impact in the oncology landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Phoenix, Arizona, United States
New Orleans, Louisiana, United States
Rochester, Minnesota, United States
New York, New York, United States
New York, New York, United States
Winston Salem, North Carolina, United States
Pierre Benite Cedex, Auvergne Rhone Alpes, France
Ramat Gan, Tel Aviv, Israel
Tel Aviv Yafo, Tel Aviv, Israel
Jerusalem, Yerushalayim, Israel
Petakh Tikva, , Israel
Nottingham, Nottinghamshire, United Kingdom
Manchester, , United Kingdom
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
Nashville, Tennessee, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Odense C, Syddanmark, Denmark
Vejle, Syddanmark, Denmark
Marseille, Bouches Du Rhone, France
Nantes, Pays De La Loire, France
Poitiers, Poitou Charentes, France
Creteil, , France
Paris, , France
Toulouse, , France
Santander, Cantabria, Spain
Majadahonda, Madrid, Spain
Salamanca, , Spain
Norwich, Norfolk, United Kingdom
Edinburgh, , United Kingdom
London, , United Kingdom
Vejle, Syddanmark, Denmark
Poitiers, Vienne, France
Haifa, H Efa, Israel
Tel Aviv, Tel Aviv, Israel
Santander, Cantabria, Spain
Pierre Benite Cedex, Rhone, France
Créteil, , France
New Orleans, Louisiana, United States
Odense, Syddanmark, Denmark
Creteil, Paris, France
Haifa, , Israel
Majadahonda, Madrid, Spain
London, London, City Of, United Kingdom
Tacoma, Washington, United States
Fort Wayne, Indiana, United States
London, Greater London, United Kingdom
Lincoln, Nebraska, United States
Cincinnati, Ohio, United States
Houston, Texas, United States
Hinsdale, Illinois, United States
Austin, Texas, United States
Tyler, Texas, United States
Fairfax, Virginia, United States
Springdale, Arkansas, United States
Newark, Delaware, United States
Aurora, Colorado, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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