Clinical trial · Interventional
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma
A Double-Blind, Randomized, Placebo-controlled Study of Two Different Schedules of Palifermin for Reduction in Severity of Oral Mucositis in Subjects With Multiple Myeloma Receiving Melphalan Followed by Autologous Blood Stem Cell Transplantation
- 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)
The purpose of this study was to evaluate the efficacy and effect of palifermin on the incidence of oral mucositis in subjects with multiple myeloma receiving Melphalan followed by autologous peripheral blood stem cell transplantation. Amendment 01 (April 07) introduced three cataract assessments to be carried out at Screening, Month 6 and Month 12 in response to FDA and EMEA follow up measures.
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 | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palifermin before and after | Drug | — | UNRESOLVED |
| Palifermin before only | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Palifermin before only
- description
- Subjects received palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
- interventionNames
- Drug: Palifermin before only
- type
- PLACEBO_COMPARATOR
- label
- Placebo (suger pill)
- description
- Subjects received matched placebo before- and after-high dose chemotherapy
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Palifermin before and after
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Multiple myeloma (MM) subjects scheduled to receive high-dose Melphalan in a one day schedule followed by autologous peripheral blood progenitor cell (PBSCT) * Body Mass Index (BMI) ≤ 35 * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, or an ECOG status of 3 if the reason for a status of 3 is exclusively due to MM (e.g. pathological fracture) * Functional hematopoietic, hepato-renal and pulmonary systems * Subjects at minimum with a baseline best corrected visual acuity (BCVA) of 20/40, (6/12 or 0.5 on the decimal scale) or better using the ETDRS chart in one eye * Subject at minimum with one eye with a natural, intact lens * Subject who has a LOCS III score at baseline of P \< 1.0, C \< 2.0 and NO \< 2.0 in at least one eye * Women in child bearing potential must have a negative pregnancy test Exclusion Criteria: * Presence or history of any other malignancy (other than curatively treated basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or other surgically cured malignancy, without evidence of disease for \> 3 years * Prior autologous or allogeneic transplants * Prior treatment with palifermin, or other fibroblast or keratinocyte growth factors * Receiving dialysis * History of cataract surgery in both eyes * Incapable of being responsive to mydriatic agents * History of other ocular disease (e.g., macular degeneration, glaucoma, corneal disease) that would make assessment of visual status difficult * Subject is scheduled to undergo cataract surgery * Subject with any disease, that in the opinion of the ophthalmologist, could adversely effect the subject's vision during the course of the study * Currently active oral mucositis infection * Positive for HIV, hepatitis B or C * Subject is unable or unwilling to follow with study procedures * Subject is pregnant or is breast feeding * Subject has not agreed to use adequate contraceptive precautions
References
Publications (0)
Data not yet available