Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma - Full Text View

Sponsor:	Roswell Park Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00054158

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 II

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)

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Thalidomide Vincristine Doxorubicin Doxorubicin hydrochloride Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate Vincristine sulfate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

August 2004

Detailed Description:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054158

Locations

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators

Roswell Park Cancer Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Asher A. Chanan-Khan, MD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00054158 History of Changes
Other Study ID Numbers:	CDR0000269903, RPCI-RP-0215
Study First Received:	February 5, 2003
Last Updated:	August 23, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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 February 12, 2012