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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01695590
Recruitment Status : Unknown
Verified May 2013 by Prolexys Pharmaceuticals.
Recruitment status was:  Recruiting
First Posted : September 28, 2012
Last Update Posted : June 4, 2013
Information provided by (Responsible Party):
Prolexys Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: PRLX 93936 Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2, Multi-center, Open Label, Dose Escalation, Safety, Efficacy and PK Study of PRLX 93936 Administered IV 3 Days a Week for 3 Weeks Followed by a 9 Day Rest Period in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
Study Start Date : March 2012
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
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
Drug: 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 Measures :
  1. Maximum Tolerated Dose [ Time Frame: Cycle 1 (28 days from first dose) ]

Secondary Outcome Measures :
  1. Response to treatment [ Time Frame: Each cycle (assessed every 28 days starting from first dose, for up to 8 months) ]
  2. Time to response [ Time Frame: From date of first dose to date of response, assessed up to 8 months ]
  3. Duration of response [ Time Frame: 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 ]
  4. Time to progression [ Time Frame: From date of first dose to first documented progression, assessed up to 8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01695590

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United States, Massachusetts
Tufts Medical Center Withdrawn
Boston, Massachusetts, United States, 02111
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Amy Destefanis    617-632-6752   
Principal Investigator: Robert Schlossman, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Barbara Riff    919-843-7046   
Contact: Katherine McKernan    919-966-4432   
Principal Investigator: Peter Voorhees, MD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Kimberly Oates    919-668-6524   
Principal Investigator: Cristina Gasparetto, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Sue O'Gara    513-604-3982   
Principal Investigator: John Morris, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Cindy Farley    615-329-7237   
Principal Investigator: Jesus G. Berdeja, MD         
Sponsors and Collaborators
Prolexys Pharmaceuticals
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Principal Investigator: Paul Richardson, MD Dana-Farber Cancer Institute
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Responsible Party: Prolexys Pharmaceuticals Identifier: NCT01695590    
Other Study ID Numbers: PRLX93936-0002
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: May 2013
Keywords provided by Prolexys Pharmaceuticals:
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases