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Safety and Efficacy Study of High Dose Melphalan to Treat Multiple Myeloma

NCT ID: NCT01572688

Last Updated: 2012-08-02

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

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-06-30

Brief Summary

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The purpose of the study is to evaluate the safety and effectiveness of melphalan for injection for autologous stem cell transplant in multiple myeloma

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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autologous stem cell transplant

Group Type EXPERIMENTAL

Melphalan

Intervention Type DRUG

powder for injection, 200mg/m2, uses after reconstituted within 24 hours

Interventions

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Melphalan

powder for injection, 200mg/m2, uses after reconstituted within 24 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with greater or equal to 18 years, with a upper age limit of 65 years are eligible.
* Multiple myeloma patients, symptoms conform to diagnosis of multiple myeloma of IMWG2003/WHO2008 criteria.
* Patients with responsive disease after induction therapy not more than 6 courses of treatment
* A complete response
* A very good partial response
* A partial response
* At least 4 weeks long from last cytotoxic treatment(exclude Bortezomib, thalidomide, dexamethasone);
* Eastern Cooperative Oncology Group (ECOG) scored 0 or 1 Patient has an absolute neutrophil count of ≥1.5×109/L and platelet count≥80×109/L;
* Calculated creatinine clearance \>50ml/min by Cockcroft-Gault formula or collect urine within 24 hours.
* Patient with a total bilirubin ≤1.5 times of normal upper limit, AST,ALT≤2.5times of normal upper limit;
* Cardio-pulmonary function is adequate to conduct autologous stem cell transplant.
* Ratio of body weight and ideal body weight \<175%;
* All patients should have a life expectancy of more than 12 weeks
* Signed informed consent form voluntarily

Exclusion Criteria

* CD34 positive hematopoietic stem cell collected \<2.0×106/kg
* Patients have a psychiatric history
* Female subject is pregnant or breast-feeding
* Patients are hypersensitive to this trial product or other alkylating agents
* Participate of other clinical trials within the past 4 weeks Active CNS lesions
* Concomitant of active infection or positive of HIV antibody
* Concomitant of other un-healed malignancy
* Left ventricular ejection fraction≤50%
* Patients with serious thrombosis
* Any severe concomitant disease that will expose study subjects to unacceptable risks.
* Patients not suitable to enroll by investigators considerations.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Lanjin Pharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lugui Qiu, master

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Locations

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Hematologic Hospital of Chinese Academy of Medical Sciences

Tianjin, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Lu G Qiu

Role: primary

Jian J Yu, Master

Role: backup

Other Identifiers

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RG0276

Identifier Type: -

Identifier Source: org_study_id