Multiple Myeloma Clinical Trial

A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma

Summary

This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 treatment-should-you-receive-monoclonal-antibodies/" >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.

Exclusion Criteria:

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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

8

Study ID:

NCT04178902

Recruitment Status:

Terminated

Sponsor:

AbbVie

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There are 24 Locations for this study

See Locations Near You

University of Arizona Cancer Center - North Campus /ID# 219102
Tucson Arizona, 85719, United States
City of Hope /ID# 209786
Duarte California, 91010, United States
Hackensack Univ Med Ctr /ID# 221035
Hackensack New Jersey, 07601, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 215418
Providence Rhode Island, 02903, United States
Prisma Health Cancer Institute-Faris Road /ID# 219076
Greenville South Carolina, 29605, United States
Royal Adelaide Hospital /ID# 223354
Adelaide South Australia, 5000, Australia
St Vincent's Hospital Melbourne /ID# 222066
Fitzroy Victoria, 3065, Australia
Alfred Health /ID# 214665
Melbourne Victoria, 3004, Australia
Perth Blood Institute Ltd /ID# 226650
Nedlands Western Australia, 6009, Australia
Royal Perth Hospital /ID# 225498
Perth Western Australia, 6000, Australia
CHU de Nantes, Hotel Dieu -HME /ID# 215480
Nantes Pays-de-la-Loire, 44000, France
Hopital Henri Mondor /ID# 214588
Creteil , 94000, France
Sheba Medical Center /ID# 214065
Ramat Gan Tel-Aviv, 52394, Israel
Nagoya City University Hospital /ID# 214696
Nagoya shi Aichi, 467-8, Japan
National Cancer Center Hospital East /ID# 214697
Kashiwa-shi Chiba, 277-8, Japan
Kyushu University Hospital /ID# 220800
Fukuoka-shi Fukuoka, 812-8, Japan
National Cancer Center Hospital /ID# 214801
Chuo-ku Tokyo, 104-0, Japan
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 217170
Pamplona Navarra, Comunidad, 31008, Spain
Hospital Universitario Vall d'Hebron /ID# 214690
Barcelona , 08035, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 214739
Madrid , 28027, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 214672
Madrid , 28040, Spain
Hospital Universitario Virgen de la Victoria /ID# 214756
Malaga , 29010, Spain
National Taiwan University Hospital /ID# 209322
Taipei City Taipei, 10002, Taiwan
China Medical University Hosp /ID# 209323
Taichung City , 40447, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

8

Study ID:

NCT04178902

Recruitment Status:

Terminated

Sponsor:


AbbVie

How clear is this clinincal trial information?

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