Recruiting

Phase 1

Phase 2

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

Sponsor:

Prolexys Pharmaceuticals

Code:

NCT01695590

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PRLX 93936

Study Details

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.

Conditions

Multiple Myeloma

Study ID

NCT01695590

Start date

Mar, 2012

Status verified date

May, 2013

Completion date

Sep, 2014

Anticipated

Primary completion date

Mar, 2014

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PRLX 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

Interventions

PRLX 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

Primary outcome measure

Maximum Tolerated Dose [ Time Frame: Cycle 1 (28 days from first dose) ]

Central Contacts and Locations

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Amy Destefanis

617-632-6752 amyl_destefanis@dfci.harvard.edu

Principal Investigator:

Robert Schlossman, MD

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Barbara Riff

919-843-7046 barbara_riff@med.unc.edu

Katherine McKernan

919-966-4432 katherine_mckernan@med.unc.edu

Principal Investigator:

Peter Voorhees, MD

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Kimberly Oates

919-668-6524 kimberly.bartlett@duke.edu

Principal Investigator:

Cristina Gasparetto, MD

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Sue O'Gara

513-604-3982 sue.ogara@uc.edu

Principal Investigator:

John Morris, MD

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Cindy Farley

615-329-7237 cindy.farley@scresearch.net

Principal Investigator:

Jesus G. Berdeja, MD

More Information

Sponsor

Prolexys Pharmaceuticals

Last update posted

Jun 4, 2013

Last verified

May, 2013

Keywords

Myeloma
PRLX93936

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Prolexys Pharmaceuticals on 2013-06-04.