The Effects of Huang-Lian-Jie-Du-Tang(HLJDT) on the Survival of Patients With Multiple Myeloma in Maintain Therapy

NCT ID: NCT02467647

Last Updated: 2015-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-12-31

Brief Summary

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To investigate the efficacy of the combination of Thalidomide and Huang-Lian-Jie-Du-Tang on the patients with multiple myeloma in maintain therapy.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A

Arm A: HLJDT 150ml three times per day for 6 months and Thalidomide 100mg once per day for 6 months

Group Type EXPERIMENTAL

Thalidomide

Intervention Type DRUG

HLJDT

Intervention Type DRUG

B

Arm B: Thalidomide 100mg oral once per day for 6 months

Group Type ACTIVE_COMPARATOR

Thalidomide

Intervention Type DRUG

Interventions

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Thalidomide

Intervention Type DRUG

HLJDT

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients can take HLJDT

Exclusion Criteria

* patients can not take HLJDT
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role collaborator

Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Shangqin Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shangqin Liu, PhD

Role: STUDY_CHAIR

Zhongnan Hospital

Locations

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Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Shangqin Liu, Ph.D

Role: primary

86-27-67812781

References

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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.

Reference Type BACKGROUND
PMID: 15626742 (View on PubMed)

Liu 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.

Reference Type BACKGROUND
PMID: 19878271 (View on PubMed)

Related Links

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Other Identifiers

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HLJDT-2016

Identifier Type: -

Identifier Source: org_study_id

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