Use of the Medicinal Mushroom Agaricus Blazei Murill in Addition to High Dose Chemotherapy in Patients With Multiple Myeloma.
N/A
N/A
Both
Multiple Myeloma
Trial Information
Use of the Medicinal Mushroom Agaricus Blazei Murill in Addition to High Dose Chemotherapy in Patients With Multiple Myeloma.
Patients who are scheduled to undergo high dose chemotherapy for multiple myeloma will
receive in addition in a double blinded manner 60 ml of agaricus extract or placebo once
daily from the start of stem cell mobilizing therapy until one week after the end of aplasia
after high dose melphalan.
Primary endpoints will be cytokine levels of degree of activation of tumor supressor genes
before and after start of the investigational product.
Secondary endpoints will be treatment response and quality of life.
Inclusion Criteria:
- Patients scheduled to undergo high dose chemotherapy with autologous stem cell
support for multiple myeloma
Exclusion Criteria:
- None
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Cytokine levels in serum
Outcome Time Frame:
7 weeks
Safety Issue:
No
Principal Investigator
Jon-Magnus Tangen
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Hematology, Oslo University Hospital, Ulleval
Authority:
Norway: Ethics Committee
Study ID:
Ando-01
NCT ID:
NCT00970021
Start Date:
June 2009
Completion Date:
December 2011
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
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