NCT00293111

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)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 multiple-myeloma

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2006

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

1.7 years

First QC Date

February 16, 2006

Last Update Submit

May 8, 2014

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaRelapsed Multiple MyelomaRefractory Multiple Myeloma

Interventions

SDX-101 (R-Etodolac)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +6 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21231, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2006

First Posted

February 17, 2006

Study Start

February 1, 2002

Primary Completion

October 1, 2003

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

US(8)