Study of SGN-40 in Patients With Refractory or Recurrent Multiple Myeloma
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the safety and activity of SGN-40 in a weekly dosage schedule as a single agent.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Detailed Description
This is an open-label, multi-dose, single-arm, phase I, dose-escalation study to define the toxicity profile, maximum tolerated dose (MTD), pharmacokinetics, and antitumor activity of SGN-40 in patients with refractory or recurrent multiple myeloma.
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 1
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Drug: 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 Names:
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Outcome Measures
Primary Outcome Measures
- Adverse events and lab abnormalities. []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients must have refractory or recurrent secretory multiple myeloma (MM).
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Patients must have failed at least two different prior systemic therapies for MM.
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Patients may have received a maximum of five cytotoxic regimens.
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Patients who have received any of the following must complete within the specified time frame below:
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Autologous stem cell transplant - 12 weeks prior to first dose
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Nitrogen Mustard agents, Melphalan, BCNU, IVIG, or monoclonal antibody therapy - 6 weeks prior to first dose
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Chemotherapy, Radiation, or other therapies for MM - 4 weeks prior to first dose
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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.
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Patients must have an ECOG performance status of ≤ 2 and a life expectancy > three months.
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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.
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Patients must be at least 18 years of age.
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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.
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Patients must meet baseline lab data requirements.
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Patients must give written informed consent.
Exclusion Criteria:
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Patients with non-secretory MM or solitary plasmacytoma or plasma cell leukemia.
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Patients with a history of allogeneic transplantation.
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Patients receiving plasmapheresis within four weeks prior to enrollment.
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Patients undergoing major surgery within four weeks prior to enrollment.
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Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
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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.
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Patients with any active viral, bacterial, or systemic fungal infection within four weeks of enrollment.
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Patients with a history of significant chronic or recurrent infections requiring treatment.
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Patients with a history of active thrombosis within three months of enrollment.
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Patients with a history of pulmonary embolism.
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Patients with a history of migraines or severe headaches requiring medical therapy within 12 months of enrollment.
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Patients who are pregnant or breastfeeding.
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Patients with uncontrolled hypercalcemia.
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Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
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Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | James R. Berenson M.D., Inc. | West Hollywood | California | United States | 90069 |
2 | Rocky Mountain Cancer Center | Denver | Colorado | United States | 80218 |
3 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
4 | Cornell University | New York | New York | United States | 10021 |
5 | The Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Seagen Inc.
- Genentech, Inc.
Investigators
- Study Director: Nancy Whiting, PharmD, Seagen Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- SG040-0001