A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma
Stopped early · Phase 1
Conditions studied: Multiple Myeloma (MM), Cancer
In brief
This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).
Key facts
- Study ID
- NCT04178902
- Run by
- AbbVie
- People needed
- 8
- Starts
- 2020-05-19
- Expected to finish
- 2021-04-16
- Last updated by the study team
- 2021-07-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented diagnosis of multiple myeloma (MM).
- Measurable disease defined as at least 1 of the following:
- Serum monoclonal protein >= 1g/dL.
- Urine M-protein >= 200mg/24 hours.
- Serum immunoglobulin free light chain (FLC) >= 10 mg/dL (100 mg/L), provided serum FLC ratio is abnormal.
- Relapsed after or are refractory or intolerant to all established MM therapies that are both known to provide clinical benefit and locally available.
- Received at least 3 prior lines of therapy including 1 or more immunomodulatory agents, 1 or more proteasome inhibitors, and 1 or more anti-CD38 monoclonal antibodies.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Adequate hematologic, renal and hepatic function as described in the protocol.
- Echocardiogram with ejection fraction >= 50% and no other clinically significant findings that would increase the participant's susceptibility to cardiac toxicity.
You may not qualify if…
- Prior exposure to any targeted myeloid cell leukemia-1 (MCL-1) inhibitor.
- Antineoplastic therapy (including any cytotoxic, targeted and/or investigational therapy; but not including corticosteroids), within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study drug and through the last dose of study drug.
- Autologous stem cell transplant within 90 days prior to start of study drug.
- Allogenic stem cell transplant within 180 days prior to start of study drug.
- History of acute or chronic pancreatitis.
- Significant unresolved liver disease.
- History of hepatitis B or human immunodeficiency virus (HIV) infection.
Where it is running
- University of Arizona Cancer Center - North Campus /ID# 219102 — Tucson, Arizona, United States
- City of Hope /ID# 209786 — Duarte, California, United States
- Hackensack Univ Med Ctr /ID# 221035 — Hackensack, New Jersey, United States
- Lifespan Cancer Institute at Rhode Island Hospital /ID# 215418 — Providence, Rhode Island, United States
- Prisma Health Cancer Institute-Faris Road /ID# 219076 — Greenville, South Carolina, United States
- Royal Adelaide Hospital /ID# 223354 — Adelaide, South Australia, Australia
- St Vincent's Hospital Melbourne /ID# 222066 — Fitzroy, Victoria, Australia
- Alfred Health /ID# 214665 — Melbourne, Victoria, Australia
- Perth Blood Institute Ltd /ID# 226650 — Nedlands, Western Australia, Australia
- Royal Perth Hospital /ID# 225498 — Perth, Western Australia, Australia
- CHU de Nantes, Hotel Dieu -HME /ID# 215480 — Nantes, Pays de la Loire Region, France
- Hopital Henri Mondor /ID# 214588 — Créteil, France
- Sheba Medical Center /ID# 214065 — Ramat Gan, Tel Aviv, Israel
- Nagoya City University Hospital /ID# 214696 — Nagoya, Aichi-ken, Japan
- National Cancer Center Hospital East /ID# 214697 — Kashiwa-shi, Chiba, Japan
- Kyushu University Hospital /ID# 220800 — Fukuoka, Fukuoka, Japan
- National Cancer Center Hospital /ID# 214801 — Chuo-ku, Tokyo, Japan
- CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 217170 — Pamplona, Navarra, Comunidad, Spain
- Hospital Universitario Vall d'Hebron /ID# 214690 — Barcelona, Spain
- CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 214739 — Madrid, Spain
- Hospital Universitario Fundacion Jimenez Diaz /ID# 214672 — Madrid, Spain
- Hospital Universitario Virgen de la Victoria /ID# 214756 — Málaga, Spain
- National Taiwan University Hospital /ID# 209322 — Taipei City, Taipei, Taiwan
- China Medical University Hosp /ID# 209323 — Taichung, Taiwan
Full record on ClinicalTrials.gov
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