Last updated: 11/07/2018 04:37:54

Drug Use Investigation for ALKERAN (melphalan) Injection 50mg

GSK study ID
112280
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: Drug Use Investigation for ALKERAN (melphalan) Injection 50mg
Trial description: The purpose of this post-marketing surveillance is to consider the presence or absence of necessity of special investigation and grasp of the following items;
1) Grasp of actual use conditions of melphalan injection in hematopoietic stem cell transplantation
2) Grasp of safety profile of melphalan injection
- Adverse drug reactions (especially unknown or serious adverse drug reactions) and serious adverse events
- Onset of adverse drug reactions under actual use conditions of melphalan injection
- Factors likely to affect safety
3) Factors likely to affect efficacy
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of renal function disorder in subjects used immunosuppressive drugs at a time of transplantation to whom melpharan was administered.

Timeframe: 3 months

The number of adverse events in subjects with hematopoietic stem cell transplantation treated with melphalan injection

Timeframe: 3 months

Presence/absence of initial recurrence or relapse of diseases after hematopoietic stem cell transplantation

Timeframe: 3 months

Presence/absence of engraftment

Timeframe: 3 months

Occurrence of adverse drug reactions in subjects with renal function disorder to whom melpharan was administered

Timeframe: 3 months

Occurrence of adverse drug reactions in subjects with cardiac function disorder to whom melpharan was administered.

Timeframe: 3 months

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Melphalan
    • Enrollment:
    2864
    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. Results of the Drug Use Investigation Assessing the Safety and Efficacy in Use of Melphalan Injection (Alkeran® Injection 50mg) for Pretreatment of Hematopoietic Stem Cell Transplantation. Prog Med. 2013;33(4):201-211.
    Medical condition
    Cancer, Neoplasms
    Product
    melphalan
    Collaborators
    Not applicable
    Study date(s)
    August 2001 to July 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Melphalan is administered as a pretreatment drug of hematopoietic stem cell transplantation
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Melphalan is administered as a pretreatment drug of hematopoietic stem cell transplantation
    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
    2011-28-07

    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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