Agaricus Blazei Murill in Patients With Multiple Myeloma

U

Ullevaal University Hospital

Status and phase

Completed
Phase 2

Conditions

Multiple Myeloma

Treatments

Dietary Supplement: Intake of 60 ml agaricus daily in addition to chemotherapy
Dietary Supplement: Intake of 60 ml placebo daily in addition to chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00970021
Ando-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

* None

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

39 participants in 2 patient groups, including a placebo group

Water with artificial colour
Placebo Comparator group
Description:
Placebo
Treatment:
Dietary Supplement: Intake of 60 ml placebo daily in addition to chemotherapy
Extract of agaricus blazei Murill
Active Comparator group
Description:
Agaricus blazei Murill
Treatment:
Dietary Supplement: Intake of 60 ml agaricus daily in addition to chemotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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