Bellini

A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy

Brief summary

This was a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in participants with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma.

Interventional study

Status:
Completed
Conditions:
Relapsed/Refractory Multiple Myeloma
Enrollment:
291 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-031
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 99 Years.

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2

- Participant has documented relapsed or progressive multiple myeloma on or after any
regimen or who are refractory to the most recent line of therapy. Relapsed myeloma is
defined as previously treated myeloma that progresses and requires initiation of
salvage therapy, but does not meet the criteria for refractory myeloma. Refractory
myeloma is defined as disease that is nonresponsive (failure to achieve minimal
response or development of progressive disease [PD]) while on primary or salvage
therapy, or progresses within 60 days of last therapy.

- Participant must have received prior treatment with at least one, but no more than
three, prior lines of therapy for multiple myeloma. A line of therapy consists of ≥ 1
complete cycle of a single agent, a regimen consisting of combination of several
drugs, or a planned sequential therapy of various regimens.

- Prior treatment with bortezomib or other proteasome inhibitor is allowed, provided ALL
of the following criteria are met: Disease is NOT refractory to any proteasome
inhibitor, defined as no disease progression (i.e., PD, per International Myeloma
Working Group [IMWG] or European Society for Blood and Marrow Transplantation [EBMT]
criteria) while receiving proteasome inhibitor therapy or within 60 days after the
last dose, AND best response achieved with any proteasome inhibitor therapy (alone or
in combination) was at least a Partial Response (PR), AND participant did not
discontinue any proteasome inhibitor due to intolerance or ≥ Grade 3 related toxicity.

- Participant has measurable disease at Screening, defined as at least one of the
following: Serum M-protein ≥ 0.5 g/dL, OR Urine M-protein ≥ 200 mg in 24-hours, OR
serum immunoglobulin free light chain (FLC) ≥ 10 mg/dL provided serum FLC ratio is
abnormal.

Exclusion Criteria:

- Participant is refractory to any proteasome inhibitor, defined as progression on or
within 60 days of the last dose of a proteasome inhibitor-containing regimen.

- Participant has had prior treatment with proteasome inhibitor within 60 days prior to
first dose of study drug.

- Participant has any of the following conditions:

Non-secretory multiple myeloma, active plasma cell leukemia i.e., either 20% of peripheral
white blood cells or greater than 2.0 X 10^9/liter (L) circulating plasma cells by standard
differential, Waldenstrom's macroglobulinemia, amyloidosis, POEMS syndrome (polyneuropathy,
organomegaly, endocrinopathy, monoclonal protein, and skin changes), known Human
Immunodeficiency Viral (HIV) infection, active hepatitis B or C infection based on blood
screen tests, significant cardiovascular disease, including uncontrolled angina, severe or
uncontrolled arrhythmia, recent myocardial infarction within 6 months of randomization, or
congestive heart failure New York Heart Association (NYHA) Class ≥ 3, major surgery within
4 weeks prior to randomization, acute infections requiring parenteral therapy (antibiotic,
antifungal, or antiviral) within 14 days prior to randomization, peripheral neuropathy ≥
Grade 3 or ≥ Grade 2 with pain within 2 weeks prior to randomization, uncontrolled diabetes
or uncontrolled hypertension within 14 days prior to randomization, any other medical
condition that, in the opinion of the Investigator, would adversely affect the
participant's participation in the study

- Participant has a history of other active malignancies, including myelodysplastic
syndrome (MDS), within the past 3 years prior to study entry, with the following
exceptions: Adequately treated in situ carcinoma of the cervix uteri or the breast,
basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin,
prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen
(PSA) levels off treatment, previous malignancy with no evidence of disease confined
and surgically resected (or treated with other modalities) with curative intent and
unlikely to impact survival during the duration of the study

- If participant had prior allogeneic stem cell transplant (SCT), participant has
evidence of ongoing graft-versus-host disease (GvHD)

All the cities where the clinical studies are located

London - N6A 4L6
Greenfield Park - J4V 2H1

Ontario

More information about this study

clinicaltrials.gov