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Efficacy Study of ZD6474 to Treat Multiple Myeloma Cancer

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 21, 2002
Last Update Posted: August 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
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

Condition Intervention Phase
Multiple Myeloma Drug: ZD6474 Drug: VEGF-receptor tyrosine kinase (KDR) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Two Study of ZD6474 in Patients With Relapsed Multiple Myeloma

Resource links provided by NLM:

Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Estimated Enrollment: 30
Study Start Date: October 2002
Study Completion Date: May 2004

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047788

United States, New York
Research Site
New York, New York, United States
Canada, Alberta
Research Site
Edmonton, Alberta, Canada
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Research Site
Hamilton, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Canada, Quebec
Research Site
Montreal, Quebec, Canada
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00047788     History of Changes
Obsolete Identifiers: NCT00052741
Other Study ID Numbers: 6474IL/0004
First Submitted: October 18, 2002
First Posted: October 21, 2002
Last Update Posted: August 24, 2016
Last Verified: August 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Relapsed Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases