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

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ClinicalTrials.gov Identifier: NCT01572688
Recruitment Status : Unknown
Verified April 2012 by Shandong Lanjin Pharmaceuticals Co.,Ltd.
Recruitment status was:  Recruiting
First Posted : April 6, 2012
Last Update Posted : August 2, 2012
Sponsor:
Information provided by (Responsible Party):
Shandong Lanjin Pharmaceuticals Co.,Ltd

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

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Melphalan Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single Arm, Open Label Study of Autologous Stem Cell Transplantation With High Dose Melphalan in Patients With Multiple Myeloma
Study Start Date : November 2011
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014


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



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572688


Locations
China
Hematologic Hospital of Chinese Academy of Medical Sciences Recruiting
Tianjin, China
Contact: Lu G Qiu    +86-022-23909172      
Contact: Jian J Yu, Master    +8615336402751    yujj@lanjin.cn   
Sponsors and Collaborators
Shandong Lanjin Pharmaceuticals Co.,Ltd
Investigators
Principal Investigator: Lugui Qiu, master Chinese Academy of Medical Sciences

Responsible Party: Shandong Lanjin Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT01572688     History of Changes
Other Study ID Numbers: RG0276
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Melphalan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs