Status:
COMPLETED
Study of SGN-40 in Patients With Refractory or Recurrent Multiple Myeloma
Lead Sponsor:
Seagen Inc.
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
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 patien...
Eligibility Criteria
Inclusion
- Patients must have refractory or recurrent secretory multiple myeloma (MM).
- Patients must have failed at least two different prior systemic therapies for MM.
- Patients may have received a maximum of five cytotoxic regimens.
- 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
- 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.
- Patients must have an ECOG performance status of ≤ 2 and a life expectancy \> three months.
- 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.
- Patients must be at least 18 years of age.
- 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.
- Patients must meet baseline lab data requirements.
- Patients must give written informed consent.
Exclusion
- Patients with non-secretory MM or solitary plasmacytoma or plasma cell leukemia.
- Patients with a history of allogeneic transplantation.
- Patients receiving plasmapheresis within four weeks prior to enrollment.
- Patients undergoing major surgery within four weeks prior to enrollment.
- Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
- 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.
- Patients with any active viral, bacterial, or systemic fungal infection within four weeks of enrollment.
- Patients with a history of significant chronic or recurrent infections requiring treatment.
- Patients with a history of active thrombosis within three months of enrollment.
- Patients with a history of pulmonary embolism.
- Patients with a history of migraines or severe headaches requiring medical therapy within 12 months of enrollment.
- Patients who are pregnant or breastfeeding.
- Patients with uncontrolled hypercalcemia.
- Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
- Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00079716
Start Date
March 1 2004
End Date
November 1 2007
Last Update
December 18 2014
Active Locations (5)
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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