Safety and Efficacy of SDX-101 (R-Etodolac) in Patients With Relapsed or Refractory Multiple Myeloma (MM)

Multiple Myeloma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00293111
• Other study ID #: SDX-101-04
• Status: Terminated
• Phase: Phase 2
• First received: February 16, 2006
• Last updated: May 8, 2014
• Start date: February 2002

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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:

1. Bone marrow plasmacytomas (10 to 30% plasma cells)

2. Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria

3. Lytic bone lesions

4. Normal IgM < 50 mg/dl, IgA < 100 mg/dl, or IgG < 600 mg/dl

2. Has relapsed or refractory disease as determined by the following:

Relapsed disease:

• Disease progression developed following the achievement of at least stable disease or better to an anti-myeloma regimen.

Refractory disease:

• Disease progression developed during therapy with an anti-myeloma regimen prior to the achievement of at least stable disease or better. Includes the development of disease progression during maintenance or consolidation therapy with glucocorticoids or cytotoxic chemotherapy.

3. Age > 18 at signing of informed consent.

4. ECOG performance status 0-2.

5. Renal function 1.5 x upper limit normal (blood urea nitrogen [BUN], serum creatinine

6. Liver function = 1.5 times upper limit of normal (total bilirubin, SGOT (AST) and SGPT (ALT) values).

7. Female patients of childbearing potential must have a negative pregnancy test (serum -human chorionic gonadotropin, -HCG); men and women of reproductive potential must employ effective contraceptive methods while on study therapy, and for 1 month following completion of treatment.

8. Signed IRB-approved informed consent by patient prior to all study related procedures.

Exclusion Criteria:

1. 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.

2. 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/mm3.

3. 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.

4. Chronic viral infection: positive hepatitis B or hepatitis C serology, known positive for human immunodeficiency virus (HIV) or human T-leukemia/lymphoma virus (HTLV).

5. Peptic ulcer disease (PUD) requiring treatment or surgical intervention within the last 2 years.

6. The use of steroids or chronic nonsteroidal anti-inflammatory drugs 28 days prior to the initiation of study medication.

7. Treatment with chemotherapy for the treatment of multiple myeloma or any investigational agent within 6 weeks of study entry.

8. History of allergy to NSAIDs or aspirin-induced asthma.

9. Pregnancy or currently breast feeding.

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• SDX-101 (R-Etodolac)

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States,