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Efficacy Study of 6474 to treat Multiple Myeloma Cancer



Efficacy Study of 6474 to treat Multiple Myeloma Cancer

For Condition: Multiple Myeloma
Status: No longer recruiting
Sponsor(s): AstraZeneca ,
Synopsis: The primary objective is to assess the efficacy of ZD6474 when given orally to patients with relapsed multiple myeloma. A minimum of 15 and a maximum of 30 evaluable patients will be entered on study
Details:
Eligibility:
Study Type:  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Confirmed diagnosis of multiple myeloma. - Patients must have a minimum serum M-protein level >=10g/L on serum protein electrophoresis or for patients with light chain only disease, a minimum Bence-Jones protein of 1g/24 hr. - Patients must have received prior treatment for multiple myeloma: patients may have received 1 or 2 prior regimens of oral alkylating based chemotherapy and must have relapsed following treatment (>= 3 months) OR patients may have relapsed following high dose chemotherapy and SCT as first line treatment provided they have not had any other treatment. - Lab at inclusion of AGC >= 1.0 x10_9/L and platelets >= 50 x10_9/L Bilirubin, AST and/or ALT <= 1.5 x UNL; creatinine < 2 x UNL, Potassium >= 4.0 mmol/L; calcium and magnesium within normal limits· - Patients may not have had > 2 prior regimens of chemotherapy and/or prior thalidomide treatment. - Patients may not have had any non-alkylating based chemotherapy. Exclusion Criteria: - Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for >= 5 years. - Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test within 7 days prior to registration and must be using effective contraception throughout the study. - Patients who have relapsed during treatment with oral alkylating chemotherapy. - Patients who have received more than 2 prior regimens of chemotherapy. - Patients who have received excluded medication or have excluded medical conditions. - Patients who have received any non-alkylating based chemotherapy regimens as initial therapy, or as therapy for recurrent disease.
Total Enrollment: 30

Location and Contact Information:


Additional Information:
Study ID Numbers:  6474IL/0004;  IND.145(Canada)
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047788

Other Multiple Myeloma Studies:
1. Randomized double cord blood transplant study

2. Total Therapy II

3. Mycophenolate Mofetil, Tacrolimus, Daclizumab, and Donor Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

4. High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer

5. Active Immunization of Sibling Bone Marrow Transplant Donors Against Purified Myeloma Protein of the Recipient Undergoing Allogeneic Bone Marrow Transplantation

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