Multiple MyelomaPhase 2NCT00970021
Agaricus Blazei Murill in Patients With Multiple Myeloma
A Phase 2 study testing Intake of 60 ml agaricus daily in addition to chemotherapy in people with Multiple Myeloma, run by Ullevaal University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Intake of 60 ml agaricus daily in addition to chemotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2009to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled to undergo high dose chemotherapy with autologous stem cell support for multiple myeloma
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of hematology, Oslo University Hospital, Ullevaal
Oslo, 0407
About this study
Official title: Use of the Medicinal Mushroom Agaricus Blazei Murill in Addition to High Dose Chemotherapy in Patients With Multiple Myeloma.
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Intake of 60 ml placebo daily in addition to chemotherapy, Intake of 60 ml agaricus daily in addition to chemotherapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intake of 60 ml placebo daily in addition to chemotherapyDietary supplement
Also called Water with artificial colour
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.
Intake of 60 ml agaricus daily in addition to chemotherapyDietary supplement
Also called Commercial name: AndoSan(TM)
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
| Study group | Role | What they receive |
|---|---|---|
| Water with artificial colour | Placebo comparator | Placebo Receives: Dietary Supplement: Intake of 60 ml placebo daily in addition to chemotherapy |
| Extract of agaricus blazei Murill | Active comparator | Agaricus blazei Murill Receives: Dietary Supplement: Intake of 60 ml agaricus daily in addition to chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine levels in serum
Measured: 7 weeks
Secondary outcomes (1)
Quality of Life
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Magnus Tangen, Oslo University Hospital
- Investigators
- Jon-Magnus Tangen, Principal investigator, Department of Hematology, Oslo University Hospital, Ulleval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970021
- Sponsor's protocol ID
- Ando-01
- Status last verified
- Feb 2014
- First submitted
- 1 Sep 2009
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Tangen JM, Tierens A, Caers J, Binsfeld M, Olstad OK, Troseid AM, Wang J, Tjonnfjord GE, Hetland G. Immunomodulatory effects of the Agaricus blazei Murrill-based mushroom extract AndoSan in patients with multiple myeloma undergoing high dose chemotherapy and autologous stem cell transplantation: a randomized, double blinded clinical study. Biomed Res Int. 2015;2015:718539. doi: 10.1155/2015/718539. Epub 2015 Jan 18.
PubMed 25664323
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Medicinal Mushroom Agaricus Blazei Murill in Addition to High Dose Chemotherapy in Patients With Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT00970021
- Acronym / sponsor ID
- Ando-01
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water with artificial colour | Placebo comparator | Dietary Supplement: Intake of 60 ml placebo daily in addition to chemotherapyPlacebo |
| Extract of agaricus blazei Murill | Active comparator | Dietary Supplement: Intake of 60 ml agaricus daily in addition to chemotherapyAgaricus blazei Murill |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to undergo high dose chemotherapy with autologous stem cell support for multiple myeloma
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intake of 60 ml placebo daily in addition to chemotherapyAlso: Water with artificial colourThe 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 supplement | Water with artificial colour |
| Intake of 60 ml agaricus daily in addition to chemotherapyAlso: Commercial name: AndoSan(TM)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 | Dietary supplement | Extract of agaricus blazei Murill |
Primary outcome
Cytokine levels in serum
Time frame: 7 weeks
1 secondary outcome
Quality of Life
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
- Derived from this study: PubMed 25664323Tangen JM, Tierens A, Caers J, Binsfeld M, Olstad OK, Troseid AM, Wang J, Tjonnfjord GE, Hetland G. Immunomodulatory effects of the Agaricus blazei Murrill-based mushroom extract AndoSan in patients with multiple myeloma undergoing high dose chemotherapy and autologous stem cell transplantation: a randomized, double blinded clinical study. Biomed Res Int. 2015;2015:718539. doi: 10.1155/2015/718539. Epub 2015 Jan 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon-Magnus Tangen principal investigator
Department of Hematology, Oslo University Hospital, Ulleval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intake of 60 ml agaricus daily in addition to chemotherapy in people with Multiple Myeloma, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine levels in serum (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00970021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2014; AzTrials last refreshed its copy on 6 Nov 2026.