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

August 1, 2012 updated by: Shandong Lanjin Pharmaceuticals Co.,Ltd

A Multicenter, Single Arm, Open Label Study of Autologous Stem Cell Transplantation With High Dose Melphalan in Patients With Multiple Myeloma

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China
        • Recruiting
        • Hematologic hospital of Chinese academy of medical sciences
        • Contact:
          • Jian J Yu, Master
          • Phone Number: +8615336402751
          • Email: yujj@lanjin.cn
        • Contact:
          • Lu G Qiu
          • Phone Number: +86-022-23909172

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: autologous stem cell transplant
Drug: Melphalan
powder for injection, 200mg/m2, uses after reconstituted within 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1 year Progression Free Survival
Time Frame: 20 months
Plan to enroll all trial subjects within 8 months and follow up 1 year for each subject after enrollment
20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Lanjin Pharmaceuticals Co.,Ltd

Investigators

  • Principal Investigator: Lugui Qiu, master, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

April 4, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (Estimate)

April 6, 2012

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG0276

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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