A Phase 1 interventional study of Venetoclax and ABBV-838 in Multiple Myeloma, sponsored by AbbVie. Withdrawn at 3 sites in Australia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-06-05.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
This is an open-label, multicenter clinical trial designed to evaluate the safety and potential efficacy of venetoclax and ABBV-838 combination therapy with dexamethasone in participants with relapsed or refractory multiple myeloma (MM) who have received 2 or more prior lines of therapy for multiple myeloma (MM). The study will consist of 2 arms: Arm A and Arm B (if applicable). Each arm will have a dose escalation and dose expansion portion.
The study will consist of 2 arms: Arm A and Arm B (if applicable). Arm A dose escalation will investigate up to 3 doses of ABBV-838 at 3-week dosing intervals (Q3W) in combination with venetoclax and dexamethasone. Arm A dose expansion portion will investigate the ABBV-838 Q3W dosing interval with venetoclax and dexamethasone at the recommended phase two dose (RPTD) combination defined from the Dose Escalation portion.
Based on data from the ongoing ABBV-838 monotherapy study (Study M14-467) Arm B dose escalation may be conducted, if deemed necessary. If conducted, Arm B dose excalation will investigate up to 3 doses of ABBV-838 at either weekly (Q1W) or bi-weekly (Q2W) dosing intervals in combination with venetoclax and dexamethasone. Arm B dose expansion portion will investigate either the ABBV-838 Q1W or Q2W dosing interval in combination with venetoclax and dexamethasone at the RPTD combination defined from the Dose Escalation portion.
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Exclusion Criteria:
ABBV-838 administered at cohort-defined doses every 3 weeks (Q3W; starting dose 4.0 mg/kg) in combination with venetoclax (400 mg or 800 mg once daily \[QD\]) and dexamethasone (40 mg once weekly \[Q1W\]); once the maximum-tolerated-dose (MTD) and recommended phase two dose (RPTD) are determined, ABBV-838 in combination with venetoclax and dexamethasone at RPTD will be administered in a dose expansion phase of the study.
Drug: Venetoclax · Drug: ABBV-838 · Drug: Dexamethasone
Dose escalation portion will investigate either the ABBV-838 weekly (Q1W) or bi-weekly (Q2W) dosing interval in combination with venetoclax (400 or 800 mg QD) and dexamethasone (40 mg Q1W). The dose expansion portion will investigate either the ABBV-838 weekly (Q1W) or bi-weekly (Q2W) dosing interval in combination with venetoclax and dexamethasone at the RPTD combination defined from the Dose Escalation portion.
Drug: Venetoclax · Drug: ABBV-838 · Drug: Dexamethasone
Tablet
Also known as: ABT-199
Intravenous infusion
Tablet or intravenous infusion
Maximum tolerated dose (MTD), and recommended phase two dose (RPTD) of venetoclax and ABBV-838 combination therapy when administered with dexamethasone
The MTD and the RPTD of venetoclax and ABBV-838 combination therapy with dexamethasone will be determined during the dose escalation phase of the study. Once the RPTD combination has been determined, the dose expansion portion will begin.
Time frame: Minimum first cycle of dosing (21 or 28 days, depending on arm)
Number of participants with adverse events
Time frame: Up to approximately 2 years following the first dose of the last subject enrolled
Maximum observed plasma concentration (Cmax) of venetoclax
Time frame: Approximately 43 or 57 days (Treatment Arm A and Treatment Arm B, respectively)
Time to Cmax (Tmax) of venetoclax
Time frame: Approximately 43 or 57 days (Treatment Arm A and Treatment Arm B, respectively)
Area under the plasma concentration-time curve over the 24-hour dose interval (AUC0-24) of venetoclax
Time frame: Approximately 43 or 57 days (Treatment Arm A and Treatment Arm B, respectively)
Objective Response Rate (ORR)
The Objective Response Rate (ORR) is defined as the proportion of subjects with a response (Stringent Complete Response \[sCR\], Complete Response \[CR\], Very Good Partial Response \[VGPR\] or Partial Response \[PR\]) based on the International Myeloma Working Group (IMWG) criteria.
Time frame: Cycle 2 Day 1 and Day 1 of every cycle thereafter for up to 2 years following the first dose of the last subject enrolled
Cmax of ABBV-838
Time frame: Approximately 43 or 57 days (Treatment Arm A and Treatment Arm B, respectively)
Tmax of ABBV-838
Time frame: Approximately 43 or 57 days (Treatment Arm A and Treatment Arm B, respectively)
AUC over the dose interval (AUC0-τ) of ABBV-838
Time frame: Approximately 43 or 57 days (Treatment Arm A and Treatment Arm B, respectively)
Total monoclonal anti-CS1 antibody (total mAb)
Time frame: Approximately 43 or 57 days (Treatment Arm A and Treatment Arm B, respectively)
Monomethyl auristatin E (MMAE) toxin levels
Time frame: Approximately 43 or 57 days (Treatment Arm A and Treatment Arm B, respectively)
Minimal Residual Disease (MRD)
MRD will be assessed in the bone marrow by next generation sequencing (NGS). MRD negativity in bone marrow aspirates will be defined at 10-5 threshold as assessed by NGS.
Time frame: Cycle 4 Day 1 and treatment completion (up to 2 years following the first dose of the last subject enrolled)
Terminal phase elimination rate constant (β) for ABBV-838
Time frame: Cycle 1 Day 1
Terminal elimination half-life (t1/2) for ABBV-838
Time frame: Cycle 1 Day 1
This study is withdrawn, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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