Agaricus Blazei Murill in Patients With Multiple Myeloma

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Dietary Supplement: Intake of 60 ml placebo daily in addition to chemotherapy; Dietary Supplement: Intake of 60 ml agaricus daily in addition to chemotherapy

• Registration Number: NCT00970021
• Lead Sponsor: Ullevaal University Hospital

Brief 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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Primary Completion: 2011-05
• Status Verified: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-22
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Patients scheduled to undergo high dose chemotherapy with autologous stem cell support for multiple myeloma

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water with artificial colour	Intake of 60 ml placebo daily in addition to chemotherapy	Placebo
Extract of agaricus blazei Murill	Intake of 60 ml agaricus daily in addition to chemotherapy	Agaricus blazei Murill

Primary Outcome Measures

Name	Time	Method
Cytokine levels in serum	7 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of Life	4 months

Trial Locations

Locations (1)

Department of hematology, Oslo University Hospital, Ullevaal; 🇳🇴 Oslo, Norway