Clinical trial NCT02755597 (phase 3, status: suspended)
Conditions: relapsed/refractory multiple myeloma
ICD codes: G35, M15.3, M67.49, M89.09, M89.59, M94.29, Q78.6
Drugs: placebo, bortezomib, dexamethasone, venetoclax
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, ClCCN(CCCl)P1(=O)NCCCO1, C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, CC1(C)CCC(CN2CCN(CC2)C2=CC=C(C(=O)NS(=O)(=O)C3=CC=C(NCC4CCOCC4)C(=C3)[N+]([O-])=O)C(OC3=CN=C4NC=CC4=C3)=C2)=C(C1)C1=CC=C(Cl)C=C1
Reason stopped: 
    safety
  
Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 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 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.

          -  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
             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, AND best response achieved
             with any proteasome inhibitor therapy (alone or in combination) was at least a PR, AND
             participant did not discontinue any proteasome inhibitor due to intolerance or greater
             than or equal to Grade 3 related toxicity.

          -  Participant 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, OR Urine M-protein
             greater than or equal to 200 mg in 24-hours, OR serum immunoglobulin free light chain
             (FLC) greater than or equal to 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 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

          -  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).