Clinical trial · Interventional
Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis
Phase 2 Study Of High Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support In Patients With Multiple Myeloma And Primary Light Chain Amyloidosis
- 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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with multiple myeloma or primary systemic amyloidosis.
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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease-free survival at 2 years (patients with responsive disease)
Secondary outcomes (3)
- measure
- Duration of hematologic toxicity
- measure
- Time to an absolute neutrophil count
- measure
- Platelet independence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed multiple myeloma OR * Primary systemic amyloidosis resulting in significant organ dysfunction and decreased quality of life * Complete or partial response after standard chemotherapy * Primary refractory or relapsed multiple myeloma after first-line treatment with standard chemotherapy * Ineligible for higher priority national or institutional clinical studies PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 2 times normal Renal: * Creatinine less than 2.5 mg/dL or on stable hemodialysis Cardiovascular: * LVEF at least 45% Pulmonary: * DLCO at least 60% of predicted OR * Approval by pulmonologist Other: * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Concurrent participation in gene therapy trials allowed Chemotherapy: * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy: * No concurrent steroids as antiemetics during chemotherapy * No concurrent anticancer hormonal therapy Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent barbiturates or acetaminophen during chemotherapy * Concurrent participation in supportive care trials allowed
References
Publications (0)
Data not yet available