Agaricus Blazei Murill in Patients With Multiple Myeloma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Dietary Supplement: Intake of 60 ml placebo daily in addition to chemotherapy
* Dietary Supplement: Intake of 60 ml agaricus daily in addition to chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo high dose chemotherapy with autologous stem cell support for multiple myeloma Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Water with artificial colour<br>Placebo | Dietary Supplement: Intake of 60 ml placebo daily in addition to chemotherapy<br>* 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.<br>* Other names: Water with artificial colour;|
| Active Comparator: Extract of agaricus blazei Murill<br>Agaricus blazei Murill | Dietary Supplement: Intake of 60 ml agaricus daily in addition to chemotherapy<br>* 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<br>* Other names: Commercial name: AndoSan(TM);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine levels in serum |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 4 months |