Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma

Stopped early · Phase 1

Conditions studied: Multiple Myeloma

In brief

This is a Phase 1/1b, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with relapsed and refractory multiple myeloma.

Key facts

Study ID

NCT02462525

Run by

AbbVie

People needed

74

Starts

2015-05-06

Expected to finish

2017-12-06

Last updated by the study team

2018-09-13

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group Performance Status of 0 to 2
• Not eligible for stem cell/bone marrow transplant or have refused stem cell/bone marrow transplant or have relapsed after autologous or allogeneic stem cell/bone marrow transplant
• Eligible for and agree to BM aspirate prior to treatment start
• Measurable disease M component in serum (≥ 0.5 g/dL) and/or urine (≥ 0.2 g excreted in a 24 hour collection sample)
• Must have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or those who are double refractory to a PI and an immunomodulatory agent and have demonstrated disease progression (DP) on or within 60 days of completion of the last therapy; participants previously treated with an alkylating agent, in addition to an IMiD or proteasome inhibitor, are allowed to enroll in the trial
• Participants must have adequate liver, kidney, and bone morrow function
• Participants with a history of chronic heart failure must have cardiac ECHO indicating left ventricular ejection fraction (LVEF) ≥ 45% within 21 days prior to first dose of study drug
• Participants in the combination therapy arms must be eligible to receive pomalidomide/dexamethasone, bortezomib/dexamethasone or lenalidomide/dexamethasone or other approved agents per current prescribing information for MM.
• Participants who will receive combination therapy with Pomalidomide/Dexamethasone must have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy

You may not qualify if…

• Received anti-cancer therapy including chemotherapy, immunotherapy, radiation, biologic, any investigational therapy or herbal therapy within a period of 21 days prior to the first dose of ABBV-838, and have unresolved toxicities ≥ grade 2
• Concurrent metastatic solid tumors
• Non-Measurable M Protein (serum or urine) and measurable sFLC (< 100 mg/mL)
• Major surgery within 21 days prior to the first dose of ABBV-838
• Clinically significant uncontrolled condition(s) including but not limited to the following:
• Grade ≥ 3 peripheral neuropathy or grade 2 peripheral neuropathy with pain Uncontrolled hypercalcemia Active uncontrolled infection Symptomatic congestive heart failure Unstable angina pectoris or cardiac arrhythmia Psychiatric illness/social situation that would limit compliance with the study
• Major immunologic reaction to any IgG containing agent or auristatin based agent
• Participants who are taking strong CYP3A4 inhibitors
• Positive for HIV (Human Immunodeficiency Virus) or with active hepatitis B and/or C
• Corneal pathology that would limit evaluation of loss in visual acuity associated with corneal deposits.
• Prior exposure to pomalidomide for subjects enrolling in the pomalidomide/dexamethasone combination arm.

Where it is running

• The University of Chicago Medical Center /ID# 139403 — Chicago, Illinois, United States
• University of Michigan Medical Center /ID# 139402 — Ann Arbor, Michigan, United States
• Washington University School of Medicine /ID# 135708 — St Louis, Missouri, United States
• Mount Sinai Medical Center /ID# 133569 — New York, New York, United States
• The Sarah Cannon Research Institute /ID# 135814 — Nashville, Tennessee, United States
• CHRU de Lille, Hopital Claude Huriez /ID# 133634 — Lille, France
• CHU de Nantes, Hotel Dieu - HME /ID# 133633 — Nantes, France
• CHU de la miletrie, Centre d'investigation clinique /ID# 147542 — Poitiers, France
• Universitaetsklinikum Koeln /ID# 141535 — Cologne, Germany
• Universitaetklinikum Dresden /ID# 141860 — Dresden, Germany
• Universitaetsklinikum Heidelberg /ID# 140046 — Heidelberg, Germany
• Universitaetsklinikum Schleswig-Holstein /ID# 141534 — Kiel, Germany
• Universitaetsklinikum Tuebingen /ID# 141074 — Tübingen, Germany
• Universitaetsklinikum Wuerzburg /ID# 141533 — Würzburg, Germany
• Hospital Clinic de Barcelona /ID# 141643 — Barcelona, Spain
• Hospital Universitario de la Princesa /ID# 140881 — Madrid, Spain
• Hospital Universitario 12 de Octubre /ID# 140878 — Madrid, Spain
• Clinica Universitaria de Navarra /ID# 141411 — Pamplona-Navarra, Spain
• Hospital Clinico Universitario Salamanca /ID# 140880 — Salamanca, Spain

Full record on ClinicalTrials.gov

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