Clinical trial · Interventional
Melphalan and Filgrastim to Stimulate Peripheral Stem Cells in Patients With Multiple Myeloma
A Phase II Study Of Blood Stem Cell Mobilization With Intravenous Melphalan (60 MG/M2) + G-CSF In Patients With Multiple Myeloma
NCT00008268CI-TRIAL-00010765completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Melphalan and colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood. PURPOSE: Phase II trial to study the effectiveness of melphalan combined with filgrastim in stimulating peripheral stem cells in patients who have multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Biological | Filgrastim | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma * Must have received induction therapy within the past 3 months * Chemoresponsive disease * Greater than 50% reduction of monoclonal paraprotein with reduction in marrow plasma cell infiltrate or greater than 50% reduction in marrow plasma cell infiltrate if disease is non-secretory * No symptomatic pleural effusions * Eligible for stem cell transplantation PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-3 (ECOG 3 allowed only if due to bone disease or neuropathy) Life expectancy: * Not specified Hematopoietic: * Platelet count at least 150,000/mm\^3 Hepatic: * Bilirubin no greater than 2.5 mg/dL Renal: * Creatinine no greater than 2.5 mg/dL OR * Creatinine clearance greater than 51 mL/min Cardiovascular: * No symptomatic cardiomyopathy * No medically documented symptomatic cardiac arrhythmias within the past 60 days * No New York Heart Association class III congestive heart failure * No myocardial infarction within the past 6 months Other: * No other concurrent medical conditions that would preclude study * No uncontrolled infections * No other active malignancy within the past 5 years except for non-melanoma skin cancer * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior stem cell mobilization or transplantation Chemotherapy: * See Disease Characteristics * No more than 200 mg prior oral melphalan Endocrine therapy: * Not specified Radiotherapy: * No more than 3000 cGy of prior radiotherapy for myeloma Surgery: * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.