- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00293111
Safety and Efficacy of SDX-101 (R-Etodolac) in Patients With Relapsed or Refractory Multiple Myeloma (MM)
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 Overview
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University School of Medicine
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Maryland
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Baltimore, Maryland, United States, 21231
- Johns Hopkins School of Medicine
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh Cancer Institute
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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.
- Age > 18 at signing of informed consent.
- ECOG performance status 0-2.
- Renal function 1.5 x upper limit normal (blood urea nitrogen [BUN], serum creatinine
- Liver function ≤ 1.5 times upper limit of normal (total bilirubin, SGOT (AST) and SGPT (ALT) values).
- 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.
- Signed IRB-approved informed consent by patient prior to all study related procedures.
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/mm3.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Etodolac
Other Study ID Numbers
- SDX-101-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Recurrent Adult Brain TumorUnited States
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National Cancer Institute (NCI)CompletedExtensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung CancerUnited States
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National Cancer Institute (NCI)CompletedAdenocarcinoma of the Prostate | Stage IV Prostate CancerUnited States
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