The Effect of High Dose Simvastatine on Multiple Myeloma | NCT00281476

Studies
The Effect of High Dose Simvastatine on Multiple Myeloma

NCT00281476

Sponsor

Vejle Hospital

Status

Completed

Last Update Posted

Nov 1, 2011Estimated

Enrollment

10Estimated

Phase

Phase 1Phase 2

Conditions

Multiple Myeloma

Interventions

Simvastatine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Not provided

Completion Date

Nov 2007Actual

First Submitted Date

Jan 23, 2006

First Submission Date that Met QC Criteria

Jan 23, 2006

First Posted Date

Jan 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2011

Last Update Posted Date

Nov 1, 2011Estimated

Description Module

Brief Summary

The purpose of the study is to evaluate the effect of high doses of Simvastatine on bone metabolisme and biochemical markers of disease in Multiple Myeloma

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Name	Type	Description	Arm Group Labels	Other Names
Simvastatine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine		8 weeks after treatment start

Secondary Outcomes

Measure	Description	Time Frame
Changes in markers of bone metabolisme after 8 weeks of intermittend treatment with simvastatine		8 weeks after start of treatment
Toxicity according to CTC after 8 weeks of intermittend treatment with simvastatine		8 weeks after start of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

multiple myeloma-patients in need of treatment
stable og progressive disease
age = or > 18 years
performance status < 3
life expectancy > 3 months

Exclusion Criteria:

pregnancy
patients incapable of giving personally concent
renal insufficiens with creatinine clearance below 25 ml/min
alanin aminotransferasis > 2,5 x upper reference limit
thyroxine below lower reference limit
known familiar muscle-disease ar previous myopati
creatinine kinase > 10 x upper reference limit
medication with drugs with known interactions wiht simvastatine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Torben Plesner, DMSc.		Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019821	Simvastatin

Ancestor Terms

ID	Term
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided