A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Mucositis; Stomatitis
Intervention: Palifermin before only; Placebo; Palifermin before and after
Intervention description: One bolus IV injection at 60 μg/kg/day, on Days 6, 5 & 4 days before-high dose chemotherapy and one bolus IV injection at 60 μg/kg/day of matched placebo on days 0, 1 & 2 days after-high dose chemotherapy. Minimum of 4 days between before-chemotherapy and after-transplantation dosing.; One bolus IV injection at 60 μg/kg/day of matched placebo on Days 6, 5 & 4 (before-high dose chemotherapy) and on Days 0, 1 & 2 (after-high dose chemotherapy).
Minimum of 4 days between pre-chemotherapy and post-transplantation dosing.; One bolus IV injection at 60 μg/kg/day, on Days 6, 5 & 4 (before-high dose chemotherapy) and on Days 0, 1 & 2 (after-high dose chemotherapy).
Minimum of 4 days between before-chemotherapy and after-transplantation dosing.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 281.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Palifermin; KGF; Clinical Trial; Oncology; Oral Mucositis; Multiple Myeloma; Cataract

Summary:

      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.
    

Eligibility criteria:

        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