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Clinical Trials/NCT00970021
NCT00970021CompletedPhase 2

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

Ullevaal University Hospital2 sites in 1 country39 target enrollmentStarted: June 1, 2009Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
39
Locations
2
Primary Endpoint
Cytokine levels in serum

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cytokine levels in serum

Time Frame: 7 weeks

Secondary Outcomes

  • Quality of Life(4 months)

Investigators

Sponsor
Ullevaal University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jon Magnus Tangen

Senior Consultant

Oslo University Hospital

Study Sites (2)

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