NCT00970021

Agaricus Blazei Murill in Patients With Multiple Myeloma

Use of the Medicinal Mushroom Agaricus Blazei Murill in Addition to High Dose Chemotherapy in Patients With Multiple Myeloma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Ullevaal University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Extract from the mushroom Agaricus blazei Murill har been shown to have strong immunomodulating properties both in cell cultures, animal models and in humans. Furthermore antitumor properties have been shown in animal models, among them in mice with multiple myeloma. The investigators now want to investigate the effect of Agaricus as supplementary treatment in addition to chemotherapy in patients with multiple myeloma.

Detailed description

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Intake of 60 ml placebo daily in addition to chemotherapy	The patients will drink 60 ml of placebo daily from start of stem cell mobilizing treatment until one week after the end of aplasia after high dose melphalan. Duration of treatment is approximately 7 weeks.
DIETARY_SUPPLEMENT	Intake of 60 ml agaricus daily in addition to chemotherapy	The patients will drink 60 ml of agaricus extract from the start of stem cell mobilizing treatment until one week after the end of aplasia after high dose melphalan. Duration of treatment: Approximately 7 weeks

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-05-01
• Completion: 2014-02-01
• First posted: 2009-09-02
• Last updated: 2014-02-25

Locations

1 site across 1 country: Norway