A Study Evaluating the Addition of Venetoclax (ABT-199) to Patients with Multiple Myeloma who are Receiving Bortezomib and Dexamethasone as Standard Therapy

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety of venetoclax, added to treatment with bortezomib and dexamethasone in patients who have returned or resistant multiple myeloma, and are considered sensitive to or have never had proteasome inhibitors.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 2
  • Documented relapsed or progressive multiple myeloma on or after any regimen or 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 non responsive (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
  • 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 greater than or equal to 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 IMWG or European Society for Blood and Marrow Transplantation [EBMT] criteria) while receiving proteasome inhibitor therapy or within 60 days after the last dose,
    • Best response achieved with any proteasome inhibitor therapy (alone or in combination) was at least a PR
    • Proteasome inhibitor was not discontinued due to intolerance or greater than or equal to Grade 3 related toxicity
  • Has measurable disease at screening, defined as at least one of the following
    • Serum M-protein greater than or equal to 0.5 g/dL
    • Urine M-protein greater than or equal to 200 mg in 24-hours
    • Serum immunoglobulin free light chain (FLC) greater than or equal to 10 mg/dL provided serum FLC ratio is abnormal

Exclusion Criteria

  • Refractory to any proteasome inhibitor, defined as
    • Progression on or within 60 days of the last dose of a proteasome inhibitor-containing regimen
  • Has had prior treatment with proteasome inhibitor within 60 days prior to first dose of study drug
  • Has any of the following conditions
    • Non-secretory or oligo-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
      • Congestive heart failure New York Heart Association (NYHA) Class greater than or equal to 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 greater than or equal to Grade 3 or greater than or equal to 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
  • 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
  • Had prior allogeneic stem cell transplant (SCT)
  • Has evidence of ongoing graft-versus-host disease (GvHD)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shaji Kumar, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

More information

Publications

Publications are currently not available
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CLS-20315816

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