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Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma Clinical research trials and Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma. Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma clinical trial. Human subjects often get the best healthcare possible for their Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma  Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma
Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma
For Condition: Multiple Myeloma
Status: Recruiting
Sponsor(s): Seattle Genetics ,
Synopsis: The purpose of this study is to determine the safety and activity of SGN-40 in a weekly dosage schedule as a single agent.
Details: 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 3 patients will be entered into each dose-level cohort for 4 consecutive weeks. The first cohort of patients will receive a dose of 0.5 mg/kg/week of SGN-40. Dose levels will be increased in successive increments, by cohort, according to the following planned dose escalation schema: 0.5, 1, 2, 4, 8, and 16 mg/kg. Dose-escalation will continue until the MTD has been identified or a dose of 16 mg/kg has been reached, whichever comes first.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 1. Patients must have refractory or recurrent secretory multiple myeloma (MM). 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 timeframe 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: 1. Patients with non-secretory MM or solitary plasmacytoma or plasma cell leukemia. 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 who are pregnant within the last 3 months or breastfeeding. 12. Patients with uncontrolled hypercalcemia. 13. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment. 14. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent.
Total Enrollment: 21
Location and Contact Information:
The Cleveland Clinic *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting
Dana Farber Cancer Institute *Not yet recruiting*
Boston, Massachusetts, 02115
United States
Not yet recruiting
Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting
Oncotherapeutics *Recruiting*
Los Angeles, California, 90067
United States
Recruiting
Additional Information:
Study ID Numbers: SG040-0001;
Study Start Date: March 2004
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079716
Other Multiple Myeloma Studies:
1. Tipifarnib in Treating Patients With Advanced Hematologic Cancer
2. Comparison of Antibody Therapies in Treating Patients With Graft- Versus-Host Disease That Does Not Respond to Steroid Therapy
3. Phase I Study of SU006668 in Patients With Advanced Solid Tumors
4. Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon
5. Study comparing safety and efficacy of STR + melphalan to melphalan alone, with stem cell transplant in multiple myeloma
Related Studies:
Other Multiple Myeloma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma
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