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

Multiple Myeloma Clinical Trial

— MM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01572688
• Other study ID #: RG0276
• Status: Recruiting
• Phase: N/A
• First received: April 4, 2012
• Last updated: August 1, 2012
• Start date: November 2011
• Est. completion date: June 2014

Study information

• Verified date: April 2012
• Source: Shandong Lanjin Pharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Melphalan
powder for injection, 200mg/m2, uses after reconstituted within 24 hours

Locations

Country	Name	City	State
China	Hematologic Hospital of Chinese Academy of Medical Sciences	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Lanjin Pharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 year Progression Free Survival	Plan to enroll all trial subjects within 8 months and follow up 1 year for each subject after enrollment	20 months	No