High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Newly Diagnosed Stage I, Stage II, or Stage III Multiple Myeloma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, use different ways to stop cancer cells from dividing so they stop growing or die. Stem cell transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Giving colony-stimulating factors, such as G-CSF or pegfilgrastim, helps stem cells move from the bone marrow to the blood so they can be collected. It is not yet known which regimen is more effective in treating multiple myeloma.

PURPOSE: This randomized phase II trial is studying how well high-dose chemotherapy followed by stem cell transplant works in treating patients with newly diagnosed stage I, stage II, or stage III multiple myeloma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasme University Hospital
• Treatments: Lenograstim; Melphalan

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of symptomatic stage I or stage II-III multiple myeloma

• Newly diagnosed disease

• No amyloidosis

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status 0-2

• ANC ≥ 1.0 x 10^9/L (without colony-stimulating factors)

• Platelet count ≥ 50 x 10^9/L (without transfusion support within the past 7 days)

• Serum calcium < 14 mg/dL

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)

• Total bilirubin ≤ 1.5 times ULN

• Creatinine clearance ≥ 50 mL/min

• Fertile patients must use effective contraception

• Negative pregnancy test

• Willing and able to comply with protocol requirements

Exclusion criteria:

• Myocardial infarction within the past 6 months

• New York Heart Association class III or IV heart failure

• Uncontrolled angina

• Severe uncontrolled ventricular arrhythmia

• Acute ischemia or active conduction system abnormalities as evidenced by ECG

• Serious medical condition that could prolong hematological recovery or preclude completion of or tolerance to protocol therapy

• Seropositive for HIV antibody

• Known hepatitis B surface antigen positivity OR active hepatitis C infection

• Active systemic infection requiring treatment

• Pregnant or nursing

• Poor psychiatric condition

PRIOR CONCURRENT THERAPY:

• No plasmapheresis within the past 4 weeks

• No major surgery within the past 4 weeks

• No anticancer therapy within the past 5 years, except treatment for basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix

• No other concurrent G-CSF growth factors

• No concurrent enrollment in another investigational clinical trial

• No concurrent investigational agent that would contraindicate the use of pegfilgrastim as either a mobilization agent or a hematological recovery agent