An Open Label, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101 (R-Etodolac) in Patients With Relapsed or Refractory Multiple Myeloma (MM)

Cephalon8 sites in 1 country30 target enrollmentFebruary 2002

ConditionsMultiple Myeloma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Multiple Myeloma
Sponsor: Cephalon
Enrollment: 30
Locations: 8
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

An Open Label, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101 (R-Etodolac) in Patients with Relapsed or Refractory Multiple Myeloma (MM)

Registry

clinicaltrials.gov

Start Date

February 2002

End Date

October 2003

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cephalon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Previously diagnosis of multiple myeloma as determined by any two of the major criteria, or major criteria 1 plus minor criteria b, c, or d, or major criteria 3 plus minor criteria a or c, or minor criteria a, b and c or a, b, and d.
•Major criteria:
•Plasmacytomas on tissue biopsy
•Bone marrow plasmacytomas (\>30% plasma cells)
•Monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin G (IgG) \>3.5 g/dl or immunoglobulin A (IGA) \> 2.0 g/dl; kappa or lambda light chain excretion \> 1 g/day on 24 hour urine protein electrophoresis
•Minor criteria:
•Bone marrow plasmacytomas (10 to 30% plasma cells)
•Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
•Lytic bone lesions
•Normal IgM \< 50 mg/dl, IgA \< 100 mg/dl, or IgG \< 600 mg/dl

Exclusion Criteria

•History of a prior malignancy with in the last 3 years with the exception of resected basal cell carcinoma, in situ cervical cancer at any time or other resected malignancies with no evidence of recurrence 5 or more years since diagnosis.
•Patients with a hemoglobin count of \< 8.0 g/dl, platelet count of \< 50,000 cells/mm3, or an absolute neutrophil count (ANC) of \< 1000 cells/mm
•Serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, places the subject at unacceptable risk or might interfere with the achievement of the study objectives.
•Chronic viral infection: positive hepatitis B or hepatitis C serology, known positive for human immunodeficiency virus (HIV) or human T-leukemia/lymphoma virus (HTLV).
•Peptic ulcer disease (PUD) requiring treatment or surgical intervention within the last 2 years.
•The use of steroids or chronic nonsteroidal anti-inflammatory drugs 28 days prior to the initiation of study medication.
•Treatment with chemotherapy for the treatment of multiple myeloma or any investigational agent within 6 weeks of study entry.
•History of allergy to NSAIDs or aspirin-induced asthma.
•Pregnancy or currently breast feeding.