Description:

Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02462525

Link:

https://clinicaltrials.gov/show/NCT02462525

Keywords:
Versions (1) ▾
  1. 5/15/19
Copyright Holder:
See clinicaltrials.gov
Uploaded on:

May 15, 2019

DOI:
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License:
Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02462525

Eligibility Multiple Myeloma NCT02462525

Inclusion Criteria
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)
received at least 2 prior therapies including an imid and a proteasome inhibitor and have demonstrated disease progression 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
Exclusion Criteria
received anti-cancer therapy including chemotherapy, immunotherapy, radiation, biologic, or any investigational therapy within a period of 21 days, herbal therapy within 7 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