|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00522392 |
Purpose
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving bortezomib together with dexamethasone is more effective with or without lenalidomide in treating multiple myeloma.
PURPOSE: This randomized phase III trial is studying bortezomib, dexamethasone, and lenalidomide to see how well they work compared with bortezomib and dexamethasone in treating patients with multiple myeloma previously treated with dexamethasone.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: bortezomib Drug: dexamethasone Drug: lenalidomide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase III Trial of Consolidation Therapy With Bortezomib (Velcade®)- Lenalidomide (Revlimid®) -Dexamethasone (VRD) Versus Bortezomib (Velcade®) - Dexamethasone (VD) for Patients With Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen |
| Estimated Enrollment: | 392 |
| Study Start Date: | August 2007 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive bortezomib IV on days 1, 4, 8, and 11, oral lenalidomide once a day on days 1-14, and oral dexamethasone once a day on days 1-4. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
|
Drug: bortezomib
Given IV
Drug: dexamethasone
Given orally
Drug: lenalidomide
Given orally
|
|
Active Comparator: Arm II
Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral dexamethasone once a day on days 1-4. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
|
Drug: bortezomib
Given IV
Drug: dexamethasone
Given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to prior induction therapy with lenalidomide and dexamethasone (yes vs no) and whether or not they are in complete response after induction therapy at study registration (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed periodically.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must meet the following criteria at one point in the course of the disease for the original diagnosis of myeloma:
Must have completed a minimum of 1 and a maximum of 6 courses of a dexamethasone-based regimen within the past 8 weeks, including any of the following:
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness that would limit compliance with the study, including any of the following:
Must be willing and able to receive prophylaxis with aspirin (325 mg/day) or alternative prophylaxis with low molecular weight heparin or coumadin
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Show 164 Study Locations| Study Chair: | Rafael Fonseca, MD | Mayo Clinic |
| Study Chair: | S. V. Rajkumar, MD | Mayo Clinic |
More Information
| Responsible Party: | Robert L. Comis, ECOG Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00522392 History of Changes |
| Other Study ID Numbers: | CDR0000561758, ECOG-E1A05 |
| Study First Received: | August 28, 2007 |
| Last Updated: | May 12, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
stage II multiple myeloma stage III multiple myeloma stage I multiple myeloma |
|
Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Bortezomib Lenalidomide Thalidomide BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |