Multiple Myeloma MedDRA version: 6.1 Level: PT Classification code 10028228
Conditions
Interventions
Trade Name: MYOCET*INFUS 2SET 50MG
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Doxorubicin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
P
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Histologically or cytologically confirmed diagnosis of Multiple Myeloma stage I in progression, stage II and stage III, A and B according to Durie and Salmon classification. ? Age >18 years ? Life expectancy of greater than 6 months ? No previous treatment ? Normal left ventricular ejection fraction (LVEF>60%) ? ECOG performance status 60%; see Appendix F). ? Patients must have normal organ function as defined below: - total bilirubin within normal institutional limits - AST(SGOT)/ALT(SGPT) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Patients who do not meet inclusion criteria ? HAV, HBV and HCV in active phase ? History of allergic reactions attributed to compounds of similar chemical or biologic composition to Thalidomide, anthracyclines and steroids or other agents used in the study. ? Uncontrolled intercurrent illness including. ? Any previous or current malignancy at other sites, with the exception of adequately treated cone-biopsied insitu carcinoma of the cervix and adequately treated basal or squamous cell carcinoma of the skin. ? Pregnant women are excluded from this study because Thalidomide and the anthracycline have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Thalidomide and liposomal anthracycline, breastfeeding should be stopped if the mother is treated with this combination. These potential risks may also apply to other agents used in this study. ? HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Thalidomide, liposomal anthracycline and dexamethasone. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? to evaluate the efficacy of first line Thalidomide, Dexamethasone and liposomal anthracycline in terms of ORR;Secondary Objective: ? To evaluate toxicity (haematological, neurological, infectious, thrombotic and cardiological);Primary end point(s): Overall response rate | — |
Countries
Italy
Outcome results
None listed