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The Effects of Huang-Lian-Jie-Du-Tang（HLJDT) on the Survival of Patients With Multiple Myeloma in Maintain Therapy (HLJDT-2016)

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Thalidomide
HLJDT
Sponsored by
Wuhan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients can take HLJDT

Exclusion Criteria:

  • patients can not take HLJDT

Sites / Locations

  • Wuhan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall survival of patients with multiple myeloma treated with Huang-Lian-Jie-Du-Tang（HLJDT) in maintain therapy

Secondary Outcome Measures

Full Information

First Posted
June 15, 2013
Last Updated
June 9, 2015
Sponsor
Wuhan University
Collaborators
Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02467647
Brief Title
The Effects of Huang-Lian-Jie-Du-Tang（HLJDT) on the Survival of Patients With Multiple Myeloma in Maintain Therapy
Acronym
HLJDT-2016
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan University
Collaborators
Tongji Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Arm A: HLJDT 150ml three times per day for 6 months and Thalidomide 100mg once per day for 6 months
Arm Title
B
Arm Type
Active Comparator
Arm Description
Arm B: Thalidomide 100mg oral once per day for 6 months
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Type
Drug
Intervention Name(s)
HLJDT
Primary Outcome Measure Information:
Title
Overall survival of patients with multiple myeloma treated with Huang-Lian-Jie-Du-Tang（HLJDT) in maintain therapy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients can take HLJDT Exclusion Criteria: patients can not take HLJDT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shangqin Liu, PhD
Organizational Affiliation
Wuhan University
Official's Role
Study Chair
Facility Information:
Facility Name
Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shangqin Liu, Ph.D
Phone
86-27-67812781
Email
ubeliu@aliyun.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
15626742
Citation
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.
Results Reference
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PubMed Identifier
19878271
Citation
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.
Results Reference
background
Links:
URL
http://ubeliu.haodf.com
Description
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The Effects of Huang-Lian-Jie-Du-Tang（HLJDT) on the Survival of Patients With Multiple Myeloma in Maintain Therapy

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