A prospective, randomized placebo-controlled study of cryotherapy or placebo for prevention of oral mucositis (stomatitis) in patients with multiple myeloma undergoing autologous stem cell transplantation following high dose melphala
- Conditions
- Neoplasms
- Registration Number
- KCT0003949
- Lead Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
1) Patients with a confirmed diagnosis of symptomatic multiple myeloma (MM)
2) Patient has measurable disease, defined as follows: measurable disease is defined as serum M-protein = 1 g/dL or urine M-protein = 200 mg/24 hours when the patients started the primary induction therapy.
3) The MM patients who performed the peripheral blood stem cell collection and appropriate stem cell counts (at least CD34+ cells 2 x 106/kg)
4) Age 20-65 years
5) Cardiac ejection fraction = 50 % as measured by MUGA or 2D ECHO without clinically significant abnormalities
6) Performance status: ECOG (Eastern Cooperative Oncology Group) 0-2.
7) Adequate hematological function: Platelet count = 50 x 109/L, hemoglobin = 8 g/dL, (Prior RBC transfusion or recombinant human erythropoietin use is allowed), absolute neutrophil count (ANC) = 1.0 x 109/L
8) Adequate liver functions: - Transaminase (AST/ALT) < 3 X upper normal value - Bilirubin < 2 X upper normal value
9) A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are < 1 years after the onset of menopause.
10) Informed consent
1) multiple myeloma with POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin change) syndrome
2) multiple myeloma with Waldenstrom’s macroglobulinemia
3) multiple myeloma with Systemic amyloidosis
4) Patients who received an chemotheraphy within 3 weeks prior to randomization
5) Patients who received an extensive radiation therapy within 1 weeks prior to randomization
6) Patients who received an major surgery within 3 weeks prior to randomization
7) Patients who received an immuno-theraphy within 3 weeks prior to randomization
8) Calculated or measured creatinine clearance (CrCl) of < 15 mL/min
9) Severe heart disease
- New York Heart Association [NYHA] Class III to IV),
- Symptomatic ischemia
- Conduction abnormalities uncontrolled by conventional intervention.
- Myocardial infarction within four months prior to randomization.
10) Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to randomization.
11) Known human immunodeficiency (HIV) seropositive, active hepatitis C infection, and/or active hepatitis B
12) Second malignancy within the past 3 years
13) Patients with myelodysplastic syndrome.
14) Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method comparision of incidences of grade III or severe oral mucositis
- Secondary Outcome Measures
Name Time Method comparision of advrese events;comparision of incidences of neutropenic fever;comparision of response rates of multiple myeloma after autologous stem cell transplantation;comparision of total days which needs total parenteral nutrition;comparision of total dose of morphine to manage pain;comparision of used antibiotics to manage infection;comparision of probability of progression-free survival after transplantation;comparision of probability of overall survival after transplantation