Clinical trial · Interventional
Melphalan and Palifermin in Treating Patients Undergoing An Autologous Peripheral Stem Cell Transplant for Stage II or III Multiple Myeloma
Phase I Dose Escalation Trial of High Dose Melphalan Conditioning Regimen With Palifermin for Cytoprotection Followed by Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma
- 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, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Keratinocyte growth factors, such as palifermin, may help prevent symptoms of mucositis, or mouth sores, in patients receiving melphalan before a peripheral stem cell transplant for multiple myeloma. PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when given together with palifermin in treating patients undergoing an autologous peripheral stem cell transplant for stage II or stage III multiple myeloma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucositis | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
| Palifermin | Biological | — | UNRESOLVED |
| quality-of-life assessment | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Palifermin & Melphalen
- description
- Palifermin 60 mcg/kg/d of the actual body weight unless actual body weight is \>40% of the Ideal body weight (IBW), then adjusted body weight (AdBW) will be used for dose calculations - administered on Day - 5,-4, - 3 and then repeated on Day +1, +2 and +3 Dose of Melphalan + Palifermin (Normal Renal Function): All given on Day -2: Dose Level 1- 200 mg/m2 I.V; Dose Level 2- 220 mg/m2 I.V; Dose Level 3- 240 mg/m2 I.V; Dose Level 4- 260 mg/m2 I.V; Dose Level 5- 280 mg/m2 I.V; Dose of Melphalan + Palifermin (Renal Dysfunction CrCl. \<60)adm. via I.V.: Dose Level 1- 140 mg/m2; Dose Level 2- 160 mg/m2; Dose Level 3- 180 mg/m2; Dose Level 4- 200 mg/m2; Dose Level 5- 220 mg/m2;
- interventionNames
- Biological: Palifermin
- Drug: melphalan
- Other: questionnaire administration
- Procedure: autologous peripheral blood stem cell transplantation
- Other: quality-of-life assessment
Primary outcomes (1)
- measure
- Maximum tolerated dose of melphalan when treated with palifermin to prevent mucositis
- timeFrame
- Days -5, -4, -3, 2, +1, +2 and +3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma * Stage II or III disease * Must have undergone successful stem cell mobilization (≥ 2.0 x 10\^6 CD34+ cells/kg) * No oral lesions from any other etiology * No unhealed mucositis from induction treatment PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * Amylase and lipase normal * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 3 times ULN * Creatinine normal (stratum 1 only) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No HIV positivity * No history of allergic reaction attributed to melphalan * No uncontrolled illness, including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * No psychiatric illness or social situation that would preclude study compliance * No hepatitis B or C positivity * No prior or concurrent pancreatitis * No known sensitivity to any of the study drugs, including E. coli-derived products PRIOR CONCURRENT THERAPY: * Prior bone marrow or stem cell transplantation allowed * No prior palifermin * More than 30 days since prior investigational agents * No concurrent dialysis * No concurrent amifostine * No concurrent prophylactic oral cryotherapy during melphalan administration * No concurrent mouthwash solutions containing any of the following: * Chlorhexidine * Hydrogen peroxide * Diphenhydramine hydrochloride * No concurrent recombinant interleukin-11 or sargramostim (GM-CSF) * No concurrent sucralfate in suspension form * Sucralfate tablets allowed * No concurrent povidone-iodine rinses * No concurrent glutamine as a prophylactic agent for mucositis * No other concurrent investigational agents * No concurrent antithymocyte globulin suppression or alemtuzumab * No concurrent rituximab
References
Publications (0)
Data not yet available