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 |
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.
(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
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