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

NCT01572688 | Unknown DMC

• 1 other identifier: RG0276
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

autologous stem cell transplant

EXPERIMENTAL

Drug: Melphalan

Interventions

Melphalan DRUG

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

autologous stem cell transplant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Lanjin Pharmaceuticals Co.,Ltd: lead

Study Sites (1)

Hematologic Hospital of Chinese Academy of Medical Sciences

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Melphalan

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Lugui Qiu, master

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 6, 2012
• Study Start: November 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 2, 2012

Record last verified: 2012-04

Locations

CN (1)