Efficacy Study of ZD6474 to Treat Multiple Myeloma Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2004-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ZD6474

Intervention Type DRUG

VEGF-receptor tyrosine kinase (KDR)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No