Clinical trial · Interventional
Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma
A Multi-Center Phase III Study of Autologous Transplantation for Patients With Multiple Myeloma Comparing Melphalan 280 mg/m2 + Amifostine With Melphalan 200 mg/m2 + Amifostine
- 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: Giving chemotherapy drugs, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. Giving chemotherapy with a peripheral stem cell transplant once or twice, using stem cells from the patient or an identical brother or sister, may allow more chemotherapy to be given so more cancer cells are killed. Giving maintenance therapy after a stem cell transplant may kill any cancer cells that remain. It is not yet known which dose of melphalan is more effective in treating multiple myeloma (MM). PURPOSE: This randomized phase III trial is studying two different doses of melphalan to compare how well they work when given together with amifostine followed by one or two autologous or syngeneic stem cell transplants and maintenance therapy in treating patients with stage II-III MM
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage III Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage II Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amifostine trihydrate | Drug | — | UNRESOLVED |
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| fluorescence in situ hybridization | Genetic | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (high dose melphalan, amifostine trihydrate, transplant)
- description
- INDUCTION THERAPY: Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
- interventionNames
- Drug: melphalan
- Drug: amifostine trihydrate
- Procedure: peripheral blood stem cell transplantation
- Genetic: fluorescence in situ hybridization
- Procedure: bone marrow ablation with stem cell support
- type
- ACTIVE_COMPARATOR
- label
- Arm II (low dose melphalan, amifostine trihydrate, transplant)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have MM undergoing autologous or syngeneic hematopoietic transplantation * Patients must meet Salmon and Durie criteria for initial diagnosis of MM * Transplant will be offered to patients with stage II or III MM * Measurable disease, defined as serum monoclonal protein \>= 0.2 g/dl or Bence Jones protein \>= 200 mg/24 h * Karnofsky \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2 * Life expectancy is not severely limited by concomitant illness * Left ventricular ejection fraction \>= 50% * No uncontrolled arrhythmias or symptomatic cardiac disease * Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and diffusion capacity of carbon monoxide (DLCO) \>= 50% * No symptomatic pulmonary disease * Human immunodeficiency virus (HIV) negative * Bilirubin \< 2 mg/dl * Serum glutamic pyruvate transaminase (SGPT) \< 2.5 x normal * Creatinine clearance \>= 60 cc/min, estimated or measured * Signed informed consent Exclusion Criteria: * Pregnant or lactating females * Uncontrolled infection * Planned tandem autologous/reduced intensity allograft * Insufficient PBSC for an autologous transplant (\< 3.0 x 10\^6 CD34+ cells/kg total) * Prior autologous transplant * Non-secretory myeloma and patients who are in a complete response or near complete response after conventional therapy * Patients unwilling to practice adequate forms of contraception if clinically indicated * Male patients on study need to be consulted to use latex condoms, even if they have had a vasectomy, every time they have sex with a woman who is able to have children * Patients with history of seizures * Patients receiving antihypertensive therapy that cannot be stopped for 24 hours preceding amifostine treatment
References
Publications (0)
Data not yet available