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

Status: Recruiting
Phase: Phase 1
Diagnosis: Multiple Myeloma
NCT ID: NCT00461045 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 06-064

 

This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the proteasome inhibitor NPI-0052 in patients with relapsed or relapsed/refractory multiple myeloma. By inhibiting proteasomes NPI-0052 prevents the breakdown of proteins involved in signal transduction, which blocks growth and survival in cancer cells.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Paul Richardson, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Deborah Doss, 617-632-5672, ddoss@partners.org

Eligibility Criteria

Inclusion Criteria: - Age >=18 years - Karnofsky Performance Status (KPS) >=70% - Histologic evidence of multiple myeloma, relapsed or relapsed/refractory disease for which no other approved treatment is available and clinically indicated - 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 >= 1.5 x 10^9 /L - Platelet count >= 75 x 10^9 /L (without transfusions) - Signed informed consent Exclusion Criteria: - Administration of chemotherapy, radiation, biological, immunotherapy or investigational agent within 28 days (6 weeks for nitrosourea and 12 weeks for BMT) - Patients may be receiving steroids or bisphosphonates, but doses must be stable - Patients must be off intrathecal therapy for at least 3 months prior to dosing - Ongoing coagulopathies and/or taking anticoagulants - Patients with evidence of mucosal or 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 - Any other medical conditions that would impose excessive risk to the patient
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