Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma
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Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining chemotherapy with thalidomide may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and thalidomide in treating patients who have newly diagnosed stage I, stage II, or stage III multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: thalidomide Drug: vincristine sulfate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of VAD (Vincristine, Adriamycin, Dexamethasone) Plus Thalidomide (Low Dose) as Frontline Therapy for Newly Diagnosed Patients With Multiple Myeloma (MM) |
| Enrollment: | 24 |
| Study Start Date: | August 2004 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the overall response rate in patients with newly diagnosed stage I, II, or III multiple myeloma treated with vincristine, doxorubicin, dexamethasone, and low-dose thalidomide.
- Determine the ability to collect peripheral blood stem cells in patients after treatment with this regimen.
OUTLINE: This is an open-label, nonrandomized study.
Patients receive vincristine IV and doxorubicin IV continuously on days 1-4 and oral dexamethasone on days 1-4, 9-12, and 17-20. Patients also receive low-dose oral thalidomide daily on days 1-28. Treatment repeats every 4 weeks for 4-6 courses in the absence of disease progression.
Patients are followed until disease progression or bone marrow transplantation.
PROJECTED ACCRUAL: Approximately 17-37 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Newly diagnosed stage I, II, or III multiple myeloma (MM)
- No refractory or relapsed MM
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin less than 1.5 mg/dL
- AST less than 2.5 times upper limit of normal
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective methods of contraception (including at least 1 highly active method) for at least 4 weeks before, during, and for at least 4 weeks after study participation
- No active serious infections uncontrolled by antibiotics
- No insufficient mental capacity that would preclude informed consent
- No other medical condition or reason that would preclude study participation
- Willing and able to comply with the FDA-mandated S.T.E.P.S program
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior thalidomide
Chemotherapy
- No more than 1 course of prior vincristine, doxorubicin, and dexamethasone
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No concurrent alcohol consumption
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Study Chair: | Asher A. Chanan-Khan, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00054158 History of Changes |
| Other Study ID Numbers: | RP 02-15, RPCI-RP-0215 |
| Study First Received: | February 5, 2003 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Roswell Park Cancer Institute:
|
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Additional relevant MeSH terms:
|
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 Doxorubicin Thalidomide Vincristine BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013