Safety and Efficacy of SDX-101 (R-Etodolac) in Patients With Relapsed or Refractory Multiple Myeloma (MM)
Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: SDX-101 (R-Etodolac) (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Cephalon
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)
Clinical Details
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)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
H. Lee Moffitt Cancer Center, Tampa, Florida 33612, United States
Emory University School of Medicine, Atlanta, Georgia 30322, United States
Johns Hopkins School of Medicine, Baltimore, Maryland 21231, United States
Roswell Park Cancer Institute, Buffalo, New York 14263, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, United States
Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania 15232, United States
MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
Starting date: February 2002
Last updated: May 8, 2014
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