A new induction therapy (ThalDoDex) for multiple myeloma. A phase II study. - ND
- Conditions
- Multiple MyelomaMedDRA version: 6.1Level: PTClassification code 10028228
- Registration Number
- EUCTR2006-005831-44-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
?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 <2 (Karnofsky >60%; see Appendix F).
?Patients must have normal organ function as defined below:
-total bilirubinwithin normal institutional limits
-AST(SGOT)/ALT(SGPT)<2.5 X institutional upper limit of normal
?Low WBC, haemoglobin concentration and platelets count do not represent a limitation to treatment if it is expression of the involvement of bone marrow by the disease. The same consideration is made regarding the creatinine levels and creatinine clearance: if renal damage is induced by the disease, the combination therapy is beneficial in terms of reducing the creatinine levels.
?The effects of drug combination (Thalidomide, doxorubicin liposomal and Dexametasone) on the developing human fetus at the recommended therapeutic dose is well known for Thalidomide. For this reason and because this agent as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
?Ability to understand and the willingness to sign a written informed consent document.
?Able to comply with study protocol
?Negative pregnancy test
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
?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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method