|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | California Cancer Consortium |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00022607 |
Purpose
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. It is not yet known whether bevacizumab works better with or without thalidomide for multiple myeloma.
PURPOSE: This randomized phase II trial is to see if bevacizumab works better with or without thalidomide in treating patients who have relapsed or refractory multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Biological: bevacizumab Drug: thalidomide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed/Refractory Multiple Myeloma |
| Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior treatment with thalidomide (yes vs no).
Patients who have received no prior treatment with thalidomide are randomized to 1 of 2 treatment arms.
Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 3 months and then every 3-4 months for 3 years.
PROJECTED ACCRUAL: A total of 55-103 patients (16-32 who have received prior thalidomide, 16-32 in arm I, and 23-39 in arm II) will be accrued for this study within 2.5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed progressing multiple myeloma
Smoldering myeloma is eligible provided there is evidence of progressive disease requiring therapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No arterial thromboembolic event within the past 6 months, including any of the following:
Pulmonary:
Other:
No peripheral neuropathy or CNS abnormalities ≥ grade 2
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Prior nonmyeloablative transplantation allowed provided the following are true:
Chemotherapy:
No more than 5 prior chemotherapy regimens
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
More Information
| Study ID Numbers: | CDR0000068834, CCC-PHII-30, CHNMC-PHII-30, CHNMC-IRB-01006, NCI-2712 |
| Study First Received: | August 10, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00022607 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
|
Anti-Infective Agents Thalidomide Immunologic Factors Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Bevacizumab Hemostatic Disorders Anti-Bacterial Agents Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents |
Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Growth Substances Vascular Diseases Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Multiple Myeloma Neoplasms Lymphoproliferative Disorders Neoplasms, Plasma Cell Leprostatic Agents |