Safety, Efficacy and Pharmacokinetic Study of PRLX 93936 in Patients With Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Myeloma, PRLX93936
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: PRLX 93936
Type: Drug
Overall Status
Recruiting
Summary
To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for patients with relapsed or relapsed/refractory multiple myeloma.
Detailed Description
- To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period, as treatment for patients with relapsed or relapsed/refractory multiple myeloma.

- To establish the dose of PRLX 93936 recommended for future studies.

- To characterize potential toxicities of PRLX 93936.

- To assess the pharmacokinetic profile of PRLX 93936.

- To evaluate response to treatment, time to response (TTR) and duration of response.

- To evaluate time to progression (TTP).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 ≤ 500 msec

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
Locations
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Amy Destefanis - 617-632-6752 - amyl_destefanis@dfci.harvard.edu
Tufts Medical Center
Boston, Massachusetts, United States
Status: Withdrawn
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Status: Recruiting
Contact: Barbara Riff - 919-843-7046 - barbara_riff@med.unc.edu
Duke University Medical Center
Durham, North Carolina, United States
Status: Recruiting
Contact: Kimberly Oates - 919-668-6524 - kimberly.bartlett@duke.edu
University of Cincinnati
Cincinnati, Ohio, United States
Status: Recruiting
Contact: Sue O'Gara - 513-604-3982 - sue.ogara@uc.edu
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Status: Recruiting
Contact: Cindy Farley - 615-329-7237 - cindy.farley@scresearch.net
Start Date
March 2012
Completion Date
September 2014
Sponsors
Prolexys Pharmaceuticals
Source
Prolexys Pharmaceuticals
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page