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

Back to results

Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

dexamethasone

doxorubicin hydrochloride

thalidomide

vincristine sulfate

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00054158

First Posted

February 5, 2003

Last Updated

September 30, 2022

Sponsor

Roswell Park Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT00054158

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

April 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Roswell Park Cancer Institute

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

dexamethasone

Intervention Type

Drug

Intervention Name(s)

doxorubicin hydrochloride

Intervention Type

Drug

Intervention Name(s)

thalidomide

Intervention Type

Drug

Intervention Name(s)

vincristine sulfate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Asher A. Chanan-Khan, MD

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Study Chair

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263-0001

Country

United States

Multiple Myeloma and Plasma Cell Neoplasm

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial