Last updated: 11/07/2018 04:38:11
Special Drug Use Investigation for ALKERAN (melphalan) Injection 50mg (5-year survival ratio)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Special Drug Use Investigation for ALKERAN (melphalan) Injection 50mg (5-year survival ratio)
Trial description: This post-marketing surveillance is designed to grasp the presence or absence of initial recurrence or relapse of primary diseases and a subject's prognosis (survival/death) after transplantation under actual use conditions of transplantation therapy.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The presence or absence of initial recurrence or relapse of primary diseases after transplantation
Timeframe: 5 years
A subject's prognosis (survival/death) after transplantation
Timeframe: 5 years
Secondary outcomes:
Not applicable
Interventions:
Drug: Melphalan
Enrollment:
537
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Kyosuke Haze, Emi Nishida, Soichiro Okamoto, Seiichi Naito, Terufumi Hara, Pascal Yoshida. Recurrence/Relapse and Prognosis in Patients Receiving Melphalan Injection (Alkeran Injection 50mg) for Pretreatment of Hematopoietic Stem Cell Transplantation - Results of a Special Drug Use Investigation -. Prog Med. 2013;33(4):213-218.
Medical condition
Cancer, Neoplasms
Product
melphalan
Collaborators
Not applicable
Study date(s)
June 2002 to August 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- Melphalan was administered as a pretreatment in a time of hematopoietic stem cell transplantation for treatment of leukemia, malignant lymphoma, multiple myeloma, pediatric solid tumors
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Melphalan was administered as a pretreatment in a time of hematopoietic stem cell transplantation for treatment of leukemia, malignant lymphoma, multiple myeloma, pediatric solid tumors
Exclusion criteria:
- None
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2011-11-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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