Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma
Status: | Terminated |
---|---|
Conditions: | Blood Cancer, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 9/15/2018 |
Start Date: | May 6, 2015 |
End Date: | December 6, 2017 |
A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma
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.
pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with
relapsed and refractory multiple myeloma.
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)
- 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
Exclusion Criteria:
- 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.
We found this trial at
6
sites
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5841 South Maryland Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
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