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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
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:

Interventional

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:

Continous

Safety Issue:

Yes

Principal Investigator

Robert Corringham

Investigator Role:

Study Director

Investigator Affiliation:

Triphase Research and Development I Corp, Chief Medical Officer

Authority:

United States: Food and Drug Administration

Study ID:

NPI-0052-101

NCT ID:

NCT00461045

Start Date:

March 2007

Completion Date:

December 2014

Related Keywords:

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

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Chicago, School of MedicineChicago, Illinois  60637