Last updated: 11/07/2018 04:38:11

Special Drug Use Investigation for ALKERAN (melphalan) Injection 50mg (5-year survival ratio)

GSK study ID
112282
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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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