Multiple MyelomaPhase 1HLJDT-2016NCT02467647
The Effects of Huang-Lian-Jie-Du-Tang（HLJDT) on the Survival of Patients With Multiple Myeloma in Maintain Therapy
A Phase 1 study testing Thalidomide and HLJDT in people with Multiple Myeloma, run by Wuhan University at 1 site in China.
Trial summary
To investigate the efficacy of the combination of Thalidomide and Huang-Lian-Jie-Du-Tang on the patients with multiple myeloma in maintain therapy. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Thalidomide and HLJDT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2019
- Phase
- Phase 1
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients can take HLJDT
Who cannot join
- patients can not take HLJDT
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan University
Wuhan, Hubei, 430071
Shangqin Liu, Ph.D, 86-27-67812781, ubeliu@aliyun.com
About this study
Official title: Phase 1 Study of the Effects of Huang-Lian-Jie-Du-Tang（HLJDT) on the Survival of Patients With Multiple Myeloma in Maintain Therapy
To investigate the efficacy of the combination of Thalidomide and Huang-Lian-Jie-Du-Tang on the patients with multiple myeloma in maintain therapy.
- Conditions
- Multiple Myeloma
- Being tested
- Thalidomide, HLJDT
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
HLJDTDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Arm A: HLJDT 150ml three times per day for 6 months and Thalidomide 100mg once per day for 6 months Receives: Drug: Thalidomide; Drug: HLJDT |
| B | Active comparator | Arm B: Thalidomide 100mg oral once per day for 6 months Receives: Drug: Thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival of patients with multiple myeloma treated with Huang-Lian-Jie-Du-Tang（HLJDT) in maintain therapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital
- Responsible party
- Principal investigator, Shangqin Liu, Wuhan University
- Investigators
- Shangqin Liu, PhD, Study chair, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467647
- Sponsor's protocol ID
- HLJDT-2016
- Acronym
- HLJDT-2016
- Status last verified
- Jun 2015
- First submitted
- 15 Jun 2013
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ma Z, Otsuyama K, Liu S, Abroun S, Ishikawa H, Tsuyama N, Obata M, Li FJ, Zheng X, Maki Y, Miyamoto K, Kawano MM. Baicalein, a component of Scutellaria radix from Huang-Lian-Jie-Du-Tang (HLJDT), leads to suppression of proliferation and induction of apoptosis in human myeloma cells. Blood. 2005 Apr 15;105(8):3312-8. doi: 10.1182/blood-2004-10-3915. Epub 2004 Dec 30.
PubMed 15626742Liu S, Ma Z, Cai H, Li Q, Rong W, Kawano M. Inhibitory effect of baicalein on IL-6-mediated signaling cascades in human myeloma cells. Eur J Haematol. 2010 Feb 1;84(2):137-44. doi: 10.1111/j.1600-0609.2009.01365.x. Epub 2009 Oct 28.
PubMed 19878271
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Effects of Huang-Lian-Jie-Du-Tang（HLJDT) on the Survival of Patients With Multiple Myeloma in Maintain Therapy
- ClinicalTrials.gov ID
- NCT02467647
- Acronym / sponsor ID
- HLJDT-2016 / HLJDT-2016
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Collaborators
- Tongji Hospital
- Study start
- Jan 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 10 Jun 2015 (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.
To investigate the efficacy of the combination of Thalidomide and Huang-Lian-Jie-Du-Tang on the patients with multiple myeloma in maintain therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Thalidomide, Drug: HLJDTArm A: HLJDT 150ml three times per day for 6 months and Thalidomide 100mg once per day for 6 months |
| B | Active comparator | Drug: ThalidomideArm B: Thalidomide 100mg oral once per day for 6 months |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients can take HLJDT
Key exclusion criteria (1 listed)
- patients can not take HLJDT
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 |
|---|---|---|
| Thalidomide | Drug | A, B |
| HLJDT | Drug | A |
Primary outcome
Overall survival of patients with multiple myeloma treated with Huang-Lian-Jie-Du-Tang（HLJDT) in maintain therapy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
- Background: PubMed 15626742Ma Z, Otsuyama K, Liu S, Abroun S, Ishikawa H, Tsuyama N, Obata M, Li FJ, Zheng X, Maki Y, Miyamoto K, Kawano MM. Baicalein, a component of Scutellaria radix from Huang-Lian-Jie-Du-Tang (HLJDT), leads to suppression of proliferation and induction of apoptosis in human myeloma cells. Blood. 2005 Apr 15;105(8):3312-8. doi: 10.1182/blood-2004-10-3915. Epub 2004 Dec 30.
- Background: PubMed 19878271Liu S, Ma Z, Cai H, Li Q, Rong W, Kawano M. Inhibitory effect of baicalein on IL-6-mediated signaling cascades in human myeloma cells. Eur J Haematol. 2010 Feb 1;84(2):137-44. doi: 10.1111/j.1600-0609.2009.01365.x. Epub 2009 Oct 28.
- Related InfoLink provided by the sponsor.
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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.
Shangqin Liu, PhD study chair
Zhongnan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thalidomide and HLJDT in people with Multiple Myeloma, run by Wuhan University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 10 Jun 2015. 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 China. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival of patients with multiple myeloma treated with Huang-Lian-Jie-Du-Tang（HLJDT) in maintain therapy (time frame: 6 months). 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 NCT02467647, which also lists 2 linked publications.
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 10 Jun 2015.