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


N/A
18 Years
65 Years
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

1 year Progression Free Survival

Outcome Description:

Plan to enroll all trial subjects within 8 months and follow up 1 year for each subject after enrollment

Outcome Time Frame:

20 months

Safety Issue:

No

Principal Investigator

Lugui Qiu, master

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese Academy of Medical Sciences

Authority:

China: Food and Drug Administration

Study ID:

RG0276

NCT ID:

NCT01572688

Start Date:

November 2011

Completion Date:

June 2014

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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