A Study of Venetoclax and Dexamethasone Compared 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:October 22, 2018
End Date:January 27, 2022

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A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma

A study designed to evaluate the safety and efficacy of venetoclax plus dexamethasone
(VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with
t(11;14)-positive Relapsed or Refractory Multiple Myeloma.

Subjects randomized to Arm 2 (PomDex) may elect, if eligible, to receive VenDex therapy after
documented disease progression per International Myeloma Working Group (IMWG) criteria.


Inclusion Criteria:

- Documented diagnosis of multiple myeloma (MM) based on standard IMWG criteria.

- Measurable disease at screening as defined per protocol.

- Has received at least 2 prior lines of therapy as described in the protocol.

- Has had documented disease progression on or within 60 days after completion of the
last therapy.

- Has received at least 2 consecutive cycles of lenalidomide and be refractory to
lenalidomide, as defined per protocol.

- Has received at least 2 consecutive cycles of a proteasome inhibitor (PI).

- Has MM positive for t(11;14).

- An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
2.

- Laboratory values (liver, kidney and hematology laboratory values) that meet criteria
as described per protocol.

Exclusion Criteria:

- History of treatment with venetoclax or another B-Cell Lymphoma (BCL)-2 inhibitor or
pomalidomide.

- History of other active malignancies, including myelodysplastic syndromes (MDS),
within the past 3 years (exceptions described in the protocol).

- Evidence of ongoing graft-versus-host disease (GvHD) if prior stem cell transplant
(SCT).

- Prior treatment with any of the following: allogeneic or syngeneic SCT within 16 weeks
prior to randomization; or autologous SCT within 12 weeks prior to randomization.

- Known meningeal involvement of MM.

- Concurrent conditions as listed in the protocol.
We found this trial at
14
sites
Jacksonville, Florida 32224
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Jacksonville, FL
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Cleveland, OH
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Cleveland, OH
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Detroit, Michigan 48201
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Detroit, MI
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Detroit, Michigan 48202
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Detroit, MI
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Fresno, CA
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Houston, TX
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Liverpool, New South Wales
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Liverpool,
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Los Angeles, CA
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Louisville, Kentucky 40202
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Louisville, KY
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Pittsburgh, Pennsylvania 15232
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Pittsburgh, PA
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Rochester, Minnesota 55905
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Rochester, MN
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Spartanburg, South Carolina 29303
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Spartanburg, SC
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Weston, FL
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