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Phase 1 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma

Phase 1
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

Phase 1 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma

Inclusion Criteria:

- Age >=18 years

- Karnofsky Performance Status (KPS) >=70%

- Histologic evidence of multiple myeloma, measurable relapsed or relapsed/refractory
disease for which no other approved treatment is available and clinically indicated.
In addition, patients may have undergone prior bone marrow transplantation. Disease
must be assessed within 28 days prior to treatment initiation

- Adverse Events resulting from prior chemotherapy, surgery, or radiotherapy, must have
resolved to acceptable grades

- Adequate bone marrow, renal, adrenal, pancreatic and liver function

- Hemoglobin >= 8 g/dL

- Absolute neutrophil count >= 0.5 x 10^9 /L

- Platelet count >= 30 x 10^9 /L (without transfusions)

- Signed informed consent form

- Creatinine clearance >= 40 mL/min

- Must have received at least two cycles of carfilzomib (as a single agent or in
combination with other agents) and subsequently had disease progression during or
within 60 days of therapy

Exclusion Criteria:

- Administration of chemotherapy, biological, immunotherapy or investigational agent
within 14 days; 7 days for biologically targeted therapies (6 weeks for nitrosourea
and 12 weeks for BMT). Patients must be 2 weeks from radiation therapy.

- Patient's with > grade 1 proteinuria , untreated urinary tract infection,
pre-existing kidney disease in the investigator's assessment would impose a risk to
the patient

- Evidence of mucosal, internal bleeding and/or platelet refractory

- Significant cardiac disease

- Patients with a prior hypersensitivity reaction of CTCAE Grade > 3 to therapy
containing propylene glycol or ethanol.

- Pregnant or breast-feeding women

- Significant bacterial, viral or fungal infection

- Known to be HIV positive, or positive and active for Hepatitis A, B or C

- Any other medical conditions that would impose excessive risk to the patient

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Time Frame:


Safety Issue:


Principal Investigator

Robert Corringham

Investigator Role:

Study Director

Investigator Affiliation:

Triphase Research and Development I Corp, Chief Medical Officer


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

December 2014

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • proteasome inhibitor
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



University of Michigan Ann Arbor, Michigan  48109-0624
Dana Farber Cancer Institute Boston, Massachusetts  02115
University of Chicago, School of Medicine Chicago, Illinois  60637