Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage II… (NCT00054158) | Clinical Trial Compass
CompletedPhase 2
Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma
United States24 participantsStarted 2004-08
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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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