Multiple Myeloma (Salmon-Durie stage II or III, Relapsed or refractory disease after failure of two or more treatment regimens) MedDRA version: 8.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: Certican
Pharmaceutical Form: Tablet
INN or Proposed INN: EVEROLIMUS
CAS Number: 159351696
Current Sponsor code: RAD001
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Universitaetsklinikum Schleswig-Holstein
Eligibility
Sex/Gender
All
Inclusion 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 = 3 x ULN 9. Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 11. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) 12. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin) 13. Women who are pregnant or breast feeding, or women able to conceive and unwilling to practice an effective method of birth control. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001). Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and and are therefore to be handled with care for this study 14. Severe active pulmonary disease or history of drug/radiation induced pneumonitis 15. Patients with grade 3 hypercholesterolemia/hypertriglyceridemia or = grade 2 hypercholesterolemia/hypertriglyceridemia with history of coronary artery disease (despite lipid lowering treatment if given) 16. Patients who received prior therapy with RAD001 or other mTOR inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objectives of phase I: To evaluate the safety and optimal dose of RAD001 in patients with relapsed or refractory Multiple Myeloma Salmon & Durie Stage II or III Primary Objectives of phase II: Response Rate after 6 months;Secondary Objective: Secondary Objectives of Phase II: Time to progression, duration of remission, safety and tolerability;Primary end point(s): Primary Objectives of phase I: To evaluate the safety and optimal dose of RAD001 in patients with relapsed or refractory Multiple Myeloma Salmon & Durie Stage II or III Primary Objectives of phase II: Response Rate after 6 months | — |
Countries
Germany
Outcome results
None listed