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Clinical Trials/EUCTR2010-021857-38-DK
EUCTR2010-021857-38-DK
Active, not recruiting
Phase 1

Randomized phase II trail comparing Lenalidomide with lowdose Dexamethasone versus Lenalidomide in second line multiple myeloma (MM)

Karolinska University Hospital/Huddinge0 sites60 target enrollmentDecember 12, 2011
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ConditionsMultiple myelomaMedDRA version: 17.0Level: LLTClassification code 10028231Term: Multiple myeloma in remissionSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10028233Term: Multiple myeloma without mention of remissionSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsRevlimid

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Multiple myeloma
Sponsor
Karolinska University Hospital/Huddinge
Enrollment
60
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 12, 2011
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Karolinska University Hospital/Huddinge

Eligibility Criteria

Inclusion Criteria

  • •1\. Be at least 18 years of age
  • •2\. Have a confirmed diagnosis of MM
  • •3\. Have received lenalidomide after one prior treatment for MM and have reached at least a partial response (PR), according to IMWG criteria, including two consolidating cycles
  • •4\. Have personally signed and dated a leagally effective written informed consent form prior to admission to the study
  • •5\. Must be willing and able to understand and comply with the study requirements
  • •6\. Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception
  • •7\. Male must agree to practice contraception
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •1\. Individuals who have had a stem\-cell transplant as a 2nd line treatment for MM
  • •2\. ECOG performance status \<4
  • •3\. Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening
  • •4\. Individuals whth significant psychiatric illness or a clinically significant acute/chronic uncontrolled medical condition that might affect their experience of myeloma symptoms or their ability to describe them
  • •5\. Pregnant or lactating females
  • •6\. Any other clinically significant medical disease or condition that, in the Investigator´s opinion, may interfere with protocol adherence or a subjects´s ability to give informed consent

Outcomes

Primary Outcomes

Not specified

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Randomized phase II Trial comparing Lenalidomide with lowdose dexamethasone versus Lenalidomide inSecond Line Multiple Myeloma (MM)Multiple myelomaMedDRA version: 16.1Level: LLTClassification code 10028231Term: Multiple myeloma in remissionSystem Organ Class: 100000004864MedDRA version: 16.1Level: LLTClassification code 10028233Term: Multiple myeloma without mention of remissionSystem Organ Class: 100000004864MedDRA version: 16.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
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