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

NCT01695590 | Unknown Phase 1

• 1 other identifier: PRLX93936-0002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

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

Keywords

Myeloma; PRLX93936

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  Cycle 1 (28 days from first dose)

Secondary Outcomes (4)

• 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

Study Arms (1)

PRLX 93936

EXPERIMENTAL

PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle

Drug: PRLX 93936

Interventions

PRLX 93936 DRUG

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

PRLX 93936

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Prolexys Pharmaceuticals: lead

Study Sites (6)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

WITHDRAWN

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Paul Richardson, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: September 28, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 4, 2013

Record last verified: 2013-05

Locations

US (6)