NCT00779922

Brief Summary

The purpose of this study is to determine the pharmacokinetic profile of Revlimid® in patients presenting with Multiple Myeloma and impaired renal function, the safety of Revlimid® in the enrolled patients population. and evaluate the efficacy of Revlimid®-Dexamethasone combination in patients presenting MM and impaired renal function at completion of 3 cycles of treatment.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

3.8 years

First QC Date

October 23, 2008

Last Update Submit

October 10, 2016

Conditions

Multiple MyelomaImpaired Renal Function

Keywords

Multiple Myelomaimpaired renal function

Study Arms (1)

group 1 to 5

EXPERIMENTAL
Drug: lenalidomide

Interventions

lenalidomideDRUG
group 1 to 5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented diagnosis of relapsed or refractory multiple myeloma (MM).
  • Age \> 18 years at the time of signing the informed consent form
  • Stable renal function

You may not qualify if:

  • Documented amyloidosis
  • Any prior use of Revlimid ®
  • Any contraindication to Revlimid ® and especially:
  • Lack of acceptable method of birth control for female of childbearing potential (FCPB)
  • Men who don't agree to use condom during the study and 4 weeks after the last study drug intake if their partner is a FCPB.
  • Pregnant or breast feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poitiers University Hospital

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Multiple MyelomaRenal Insufficiency

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 23, 2008

First Posted

October 24, 2008

Study Start

November 1, 2008

Primary Completion

September 1, 2012

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations

FR(1)