Description:

Study of ACY-241 Alone and in Combination With Pomalidomide and Dexamethasone in Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02400242

Link:

https://clinicaltrials.gov/show/NCT02400242

Keywords:
Versions (1) ▾
  1. 5/14/19
Copyright Holder:
See clinicaltrials.gov
Uploaded on:

May 14, 2019

DOI:
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License:
Creative Commons BY-NC 3.0
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Eligibility Multiple Myeloma NCT02400242

Eligibility Multiple Myeloma NCT02400242

Criteria
must have a documented diagnosis of mm and have relapsed or relapsed-and-refractory disease. all patients must have relapsed after having achieved at least stable disease (sd) for at least 1 cycle of treatment to at least 1 prior regimen and then developed progressive disease (pd). relapsed-and-refractory patients also have documented evidence of pd during or within 60 days of completing last treatment
must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of proteasome inhibitor unless not a candidate.
may have undergone prior treatment with pomalidomide if patient previously achieved a response of minimal response (mr) or better to pomalidomide.
must have measurable disease (serum m-protein or urine m-protein).
must have eastern cooperative oncology group (ecog) performance score of 0, 1, or 2.
must be able to take low-dose aspirin, low molecular weight heparin, or other equivalent antithrombotic or anticoagulant daily as prophylactic anticoagulation.
key exclusion criteria:
prior therapy with pomalidomide with best response of pd or sd.
prior therapy with histone deacetylase (hdac) inhibitor.
any of the following laboratory abnormalities: absolute neutrophil count(anc) < 1,000/µl, platelet count < 75,000/µl or < 50,000/µl for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells, hemoglobin < 8 g/dl, creatinine clearance < 45 ml/min according to cockcroft-gault formula. if creatinine clearance calculated from the 24 hour urine sample is ≥ 45 ml/min, patient will qualify for the trial, aspartate transaminase (ast) or alanine transaminase (alt) > 3.0 × upper limited normal (uln), serum total bilirubin > 2.0 mg/dl or > 3.0 × uln for patients with hereditary benign hyperbilirubinaemia.
hematologic growth factors are not allowed at screening or during the first cycle of phase 1a or 1b.
nonsecretory myeloma or free light chain detected in serum only (ogliosecretory).
hypersensitivity to thalidomide, lenalidomide, pomalidomide, or dexamethasone
patients who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study