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A Phase Two Study of ZD6474 in Patients With Relapsed Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

A Phase Two Study of ZD6474 in Patients With Relapsed Multiple Myeloma

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 limitsĀ·

- Patients may not have had > 2 prior regimens of chemotherapy and/or prior thalidomide

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

ZD6474 Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2002

Completion Date:

May 2004

Related Keywords:

  • Multiple Myeloma
  • Relapsed Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Research Site Albany, New York