Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Roswell Park Cancer Institute
Collaborator:
National Cancer Institute (NCI)
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Liposomal doxorubicin
Thalidomide
Vincristine
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