NCT Number: NCT00047788
Efficacy Study of ZD6474 to Treat Multiple Myeloma Cancer
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
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Research Site, Edmonton, Alberta, Canada
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
VEGF-receptor tyrosine kinase (KDR)
DrugSponsors and collaborators
Lead sponsor
Genzyme, a Sanofi Company
Industry
Registry information
Official study title
A Phase Two Study of ZD6474 in Patients With Relapsed Multiple Myeloma
Important dates
- Study start
- 2002
- Study completion
- 2004
- First posted
- Oct 21, 2002
- Registry last updated
- Aug 24, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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