Multiple Myeloma
Conditions
Keywords
Myeloma, PRLX93936
Brief 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).
Interventions
DRUGPRLX 93936
PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle, multiple cycles may be administered
Sponsors
Prolexys Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose | Cycle 1 (28 days from first dose) |
Secondary
| Measure | Time frame |
|---|---|
| Response to treatment | Each cycle (assessed every 28 days starting from first dose, for up to 8 months) |
| Time to response | From date of first dose to date of response, assessed up to 8 months |
| Duration of response | From date of response to first documented progression or death, or date last known progression-free and alive at study discontinuation, assessed up to 8 months |
| Time to progression | From date of first dose to first documented progression, assessed up to 8 months |
Countries
United States
Outcome results
None listed