Study of SGN-40 in Patients With Refractory or Recurrent Multiple Myeloma
NCT ID: NCT00079716
Last Updated: 2014-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2004-03-31
2007-11-30
Brief Summary
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Detailed Description
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A minimum of three patients will be entered into each dose-level cohort. All patients will receive a dose-loading schedule during the first two weeks. The maximum weekly dose will be 16mg/kg.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
SGN-40 (anti-huCD40 mAb)
0.5-8 mg/kg IV (in the vein) on Day 1; 0-8 mg/kg on Day 4; 0.5-16 mg/kg on Days 8 and 15; 0-16 mg/kg on Day 29.
Interventions
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SGN-40 (anti-huCD40 mAb)
0.5-8 mg/kg IV (in the vein) on Day 1; 0-8 mg/kg on Day 4; 0.5-16 mg/kg on Days 8 and 15; 0-16 mg/kg on Day 29.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients must have failed at least two different prior systemic therapies for MM.
3. Patients may have received a maximum of five cytotoxic regimens.
4. Patients who have received any of the following must complete within the specified time frame below:
* Autologous stem cell transplant - 12 weeks prior to first dose
* Nitrogen Mustard agents, Melphalan, BCNU, IVIG, or monoclonal antibody therapy - 6 weeks prior to first dose
* Chemotherapy, Radiation, or other therapies for MM - 4 weeks prior to first dose
5. Patients who have not undergone autologous stem cell transplantation must be either ineligible for stem cell transplantation or, if eligible, must have refused treatment by autologous stem cell transplantation.
6. Patients must have an ECOG performance status of ≤ 2 and a life expectancy \> three months.
7. Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution for the entire duration of the study.
8. Patients must be at least 18 years of age.
9. Females of childbearing potential must have a negative β-HCG pregnancy test result within three days of enrollment. All patients must plan to use an effective contraceptive method during the course of the study.
10. Patients must meet baseline lab data requirements.
11. Patients must give written informed consent.
Exclusion Criteria
2. Patients with a history of allogeneic transplantation.
3. Patients receiving plasmapheresis within four weeks prior to enrollment.
4. Patients undergoing major surgery within four weeks prior to enrollment.
5. Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
6. Patients with a history of other malignancies during the past five years with the exception of adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ.
7. Patients with any active viral, bacterial, or systemic fungal infection within four weeks of enrollment.
8. Patients with a history of significant chronic or recurrent infections requiring treatment.
9. Patients with a history of active thrombosis within three months of enrollment.
10. Patients with a history of pulmonary embolism.
11. Patients with a history of migraines or severe headaches requiring medical therapy within 12 months of enrollment.
12. Patients who are pregnant or breastfeeding.
13. Patients with uncontrolled hypercalcemia.
14. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
15. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent.
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Seagen Inc.
INDUSTRY
Responsible Party
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Seattle Genetics, Inc.
Principal Investigators
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Nancy Whiting, PharmD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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James R. Berenson M.D., Inc.
West Hollywood, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Cornell University
New York, New York, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Countries
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References
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Hayashi T, Treon SP, Hideshima T, Tai YT, Akiyama M, Richardson P, Chauhan D, Grewal IS, Anderson KC. Recombinant humanized anti-CD40 monoclonal antibody triggers autologous antibody-dependent cell-mediated cytotoxicity against multiple myeloma cells. Br J Haematol. 2003 May;121(4):592-6. doi: 10.1046/j.1365-2141.2003.04322.x.
Hussein M, Berenson JR, Niesvizky R, Munshi N, Matous J, Sobecks R, Harrop K, Drachman JG, Whiting N. A phase I multidose study of dacetuzumab (SGN-40; humanized anti-CD40 monoclonal antibody) in patients with multiple myeloma. Haematologica. 2010 May;95(5):845-8. doi: 10.3324/haematol.2009.008003. Epub 2010 Feb 4.
Related Links
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Related Info
Other Identifiers
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SG040-0001
Identifier Type: -
Identifier Source: org_study_id