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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

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

Key facts

Study ID

NCT01695590

Run by

Prolexys Pharmaceuticals

People needed

40

Starts

2012-03-01

Expected to finish

2014-09-01

Last updated by the study team

2013-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 ≤ 500 msec

You may not qualify if…

• 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

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
• Tufts Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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