Multiple Myeloma
Conditions
Keywords
Relapsed Multiple Myeloma
Brief summary
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
Interventions
DRUGZD6474
DRUGVEGF-receptor tyrosine kinase (KDR)
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
Canada, United States
Outcome results
None listed