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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00970021
Enrollment
39
Registered
2009-09-02
Start date
2009-06-30
Completion date
2014-02-28
Last updated
2014-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

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.

Interventions

DIETARY_SUPPLEMENTIntake 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_SUPPLEMENTIntake 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

Sponsors

Ullevaal University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Cytokine levels in serum7 weeks

Secondary

MeasureTime frame
Quality of Life4 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026