A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma



Status:Suspended
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:November 9, 2018
End Date:January 22, 2021

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A Phase 2, Open-Label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

This study is designed to evaluate the safety and preliminary efficacy of venetoclax combined
with pomalidomide and dexamethasone in subjects with relapsed or refractory (R/R) multiple
myeloma (MM) who have received at least 1 prior line of therapy. The study will consist of 2
parts: Part 1 (dose escalation) and Part 2 (dose expansion). For Part 2 the subjects will be
divided into 2 cohorts, subjects positive for t(11;14) translocation and subjects negative
for t(11;14) translocation.


Inclusion Criteria:

- Relapsed or refractory (R/R) multiple myeloma (MM) with documented evidence of
progression during or after the subject's last treatment regimen.

- Measurable disease as described in the protocol.

- Received at least 1 prior line of therapy, as described in the protocol.

- Must meet prior antimyeloma treatment parameters, as described in the protocol, and
includes:

- Received at least 2 consecutive cycles of lenalidomide or a lenalidomide containing
regimen

- Refractory to lenalidomide

- Exposed to a proteasome inhibitor (PI) alone or in combination with another agent.

- Had a response of partial response (PR) or better to prior therapy based on the
investigator's determination of response as defined by International Myeloma Working
Group (IMWG) criteria.

- Has t(11;14) status as described in the protocol and meets the following criteria:

- For Part 1: MM subjects independent of cytogenetic profile.

- For Part 2, Arm A: subject must be t(11;14) positive.

- For Part 2, Arm B: subject must be t(11;14) negative.

- An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

- Adequate kidney, liver and hematologic laboratory values.

Exclusion Criteria:

- Previous treatment with venetoclax or other BCL-2 inhibitors, or previous treatment
with pomalidomide

- Known sensitivity to any IMiDs

- Allogenic or syngeneic stem cell transplant within 6 months before the first dose of
study drug or active ongoing graft versus host disease

- Autologous stem cell transplant within 12 weeks before the first dose of study drug

- Known meningeal involvement of MM
We found this trial at
9
sites
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mi
from
Columbus, GA
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from
Barcelona,
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Boston, Massachusetts 02215
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from
Boston, MA
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from
Columbus, OH
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Durham, North Carolina 27710
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from
Durham, NC
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mi
from
Fairway, KS
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mi
from
Portland, OR
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mi
from
Saint Louis, MO
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mi
from
Wauwatosa, WI
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