NCT00047788

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 multiple-myeloma

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_2 multiple-myeloma

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2002

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

First QC Date

October 18, 2002

Last Update Submit

August 22, 2016

Conditions

Multiple Myeloma

Keywords

Relapsed Multiple Myeloma

Interventions

ZD6474DRUG
VEGF-receptor tyrosine kinase (KDR)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site

New York, New York, United States

Location

Research Site

Edmonton, Alberta, Canada

Location

Research Site

Halifax, Nova Scotia, Canada

Location

Research Site

Hamilton, Ontario, Canada

Location

Research Site

London, Ontario, Canada

Location

Research Site

Toronto, Ontario, Canada

Location

Research Site

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

vandetanib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2002

First Posted

October 21, 2002

Study Start

October 1, 2002

Study Completion

May 1, 2004

Last Updated

August 24, 2016

Record last verified: 2016-08

Locations

US(1)CA(6)