Safety, Efficacy and Pharmacokinetic Study of PRLX 93936 in Patients With Multiple Myeloma

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Multiple Myeloma
NCT ID: NCT01695590 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-220

 

To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for patients with relapsed or relapsed/refractory multiple myeloma.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Robert Schlossman, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Kathleen Colson, 617-632-6303, kathleen_colson@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria: - Patient must have a diagnosis of multiple myeloma and have relapsed or relapsed/refractory disease. - Patient must have received ≥ 2 prior anti-myeloma regimens including a proteasome inhibitor and/or immunomodulatory agent. - Patient currently requires systemic therapy. - Patient has measurable disease. - Age ≥ 18 years - Karnofsky performance status ≥ 60% - ECOG performance 0, 1 or 2 - Life expectancy of at least three months - Able to take acetaminophen - Not pregnant - Patient must have recovered from toxicities incurred as a result of any previous anti-myeloma therapy or recovered to baseline. - Patients who received an autologous stem cell transplant must be ≥ 3 months post-transplant and all associated toxicities must have resolved to ≤ CTCAE Grade 1. - QT intervals of QTc ≤ 450 msec for men and ≤ 470 msec for women Exclusion Criteria: - POEMS syndrome - Plasma cell leukemia - Primary amyloidosis - Patient has smoldering multiple myeloma or monoclonal gammopathy of unknown significance (MGUS). - Evidence of spinal cord compression or CNS complication unless controlled by appropriate therapy. - Patient received chemotherapy or other anti-cancer therapy that may be active against multiple myeloma within 3 weeks prior to the first dose of PRLX 93936. - Patient received nitrosureas within 6 weeks prior to the first dose. - Patient received corticosteroids within 2 weeks prior to the first dose. - Patient received plasmapheresis within 4 weeks prior to the first dose. - Patient had major surgery within 4 weeks prior to the first dose. - Patient had an allogeneic stem cell transplant within 6 months before first dose of PRLX 93936 or has evidence of graft versus host disease. - Patient is taking any therapy concomitantly that may be active against multiple myeloma. - Patient is currently receiving medication(s) that are principally metabolized via the cytochrome P450 3A4 enzyme pathway. - Use of any investigational agents within 28 days or 5 half-lives (whichever is shorter) of study treatment. - Patient has peripheral neuropathy of Grade 3 or greater intensity, or painful Grade 2, as defined by the NCI CTC. - Patient had a myocardial infarction within 6 months of enrollment or has NYHA Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. - Abnormal LVEF (< LLN for the institution for a patient of that age) on echocardiogram - Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to protocol. - Patient had a malignancy other than multiple myeloma within 3 years before enrollment, with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer. - Patient's clinical laboratory values meet any of the following criteria within the 7 days prior to Study Day 1: - Bilirubin > 1.5 times ULN - AST (SGOT), ALT (SGPT) and Alkaline phosphatase > 2.5 times ULN - Uncontrolled hypercalcemia (defined as serum calcium > 14 mg/dL) - Serum creatinine > 2.0 mg/dL or creatinine clearance of < 30 mL/min - ANC < 1000 cells/mm3 or < 750 cells/mm3 due to >50% marrow involvement - Platelet count < 50,000 cells/mm3 - Hemoglobin < 8.0 g/dL - Patient is known to be human immunodeficiency virus (HIV)-positive. - Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection. - Patient has an active systemic infection requiring treatment or within 14 days before first dose of PRLX 93936. - Pregnant or nursing women
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