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Clinical Trials/EUCTR2006-002675-41-DE
EUCTR2006-002675-41-DE
Active, not recruiting
Not Applicable

A non-randomised, multi-center Phase I/II trial of safety, tolerability and efficacy of Everolimus (RAD001) in relapsed or refractory Multiple Myeloma

niversitaetsklinikum Schleswig-Holstein0 sitesDecember 15, 2006
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ConditionsMultiple Myeloma (Salmon-Durie stage II or III, Relapsed or refractory disease after failure of two or more treatment regimens)MedDRA version: 8.1Level: LLTClassification code 10028228Term: Multiple myeloma
DrugsCertican

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Myeloma (Salmon-Durie stage II or III, Relapsed or refractory disease after failure of two or more treatment regimens)
Sponsor
niversitaetsklinikum Schleswig-Holstein
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 15, 2006
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversitaetsklinikum Schleswig-Holstein

Eligibility Criteria

Inclusion Criteria

  • •1\. Multiple myeloma of Salmon\-Durie stage II or III
  • •2\. Relapsed or refractory disease after failure of two or more treatment regimens
  • •3\. Age \= 18
  • •4\. WHO performance status \= 2
  • •5\. Measurable disease marker (M component in serum or/and urine). In oligo\-secretory disease serum free light chain assay can be used as disease marker according to the International uniform response criteria for Multiple Myeloma” if the kappa/lambda\-ratio is abnormal and the involved light chain is \= 10 mg/dl.
  • •6\. Life expectancy \> 6 months
  • •7\. Adequate bone marrow function as shown by leukocytes \> 2,500/mm3 and platelets \>50,000/mm3 and hemoglobin \= 8g/dl
  • •8\. Adequate liver function as shown by:
  • •serum bilirubin \= 1\.5 x upper limit of normal (ULN), and serum transaminases activity
  • •9\. Signed informed consent

Exclusion Criteria

  • •1\. Concomitant treatment with other anti\-myeloma drugs in last 4 weeks, also including clarithromycin, thalidomide and its derivates. Aminobisphosphonates are allowed and recommended.
  • •2\. Any active infection at start of therapy which requires treatment
  • •3\. Any concomitant surgery except kyphoplasty
  • •4\. Radiotherapy (concomitantly or in the last 4 weeks) if not restricted to a single osteolytic lesion
  • •5\. Chronic treatment with steroids (\> 5 mg predisolon equivalent) or another immunosuppressive agent
  • •6\. Prior treatment with any investigational drug within the preceding 4 weeks
  • •7\. Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
  • •8\. Plasma cell leukemia
  • •9\. Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure \- New York Heart Association Class III or IV, ventricular arrhythmias active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration)
  • •10\. A known history of HIV seropositivity

Outcomes

Primary Outcomes

Not specified

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