Patients With Newly Diagnosed Multiple Myeloma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: Lenalidomide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
Current Sponsor code: CC-5013
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
FONDAZIONE NEOPLASIE SANGUE ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient Selection A. Inclusion criteria 1. Newly diagnosed multiple myeloma patients with an HLA identical sibling suitable for PBSC donation. 2. Complete cytogenetic analysis at diagnosis, including FISH analysis for chromosome deletions 13 and 17, and translocations (4;14) (11;14) and (14;16). 3. The patient must have the capacity to give informed consent. 4. Age >18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient selection 1. Karnofsky score less than 60 (see appendix C), unless due solely to myeloma 2. Left ventricular ejection fraction less than 40%, or symptomatic coronary artery disease or other cardiac failure requiring therapy 3. Bilirubin greater than 2 X the upper limit of normal, or SGPT and SGOT > 4 X the upper limit of normal 4. DLCO 20% risk of disease recurrence 9. Seropositive for HIV 10. Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment Donor selection 1. Identical twin 2. Age less than 12 years 3. Pregnancy 4. Infection with HIV 5. Inability to achieve adequate venous access 6. Known allergy to G-CSF 7. Current serious systemic illness 8. Failure to meet common criteria for stem cell donation as described in the standard practice guidelines of EBMT. F. Pregnant or lactating females. Pregnancies Pregnancies and suspected pregnancies (including a positive pregnancy test regardless of age or disease state) of a female subject or the female partner of a male subject occurring while the subject is on study drug, or within 30 days of the subject?s last dose of study drug, are considered immediately reportable events. Study drug is to be discontinued immediately and the subject instructed to return any unused portion of the study drug to the Investigator(s). The pregnancy, suspected pregnancy, or positive pregnancy test must be reported to Celgene S.r.l., ,. immediately by phone (Tel +39-02-91434340) and facsimile (Fax +39-02-63471119 or drugsafety-italy@celgene.com) using the Pregnancy Reporting Form. The female should be referred to a physician specialized or experienced in teratology for further evaluation and counseling. The Investigator(s) will follow the female subject until completion of the pregnancy, and must notify Celgene S.r.l, of the outcome of the pregnancy as a follow-up to the initial report. If the outcome of the pregnancy meets the criteria for immediate classification as a SAE (i.e., spontaneous or therapeutic abortion [any congenital anomaly detected in an aborted fetus is to be documented], stillbirth, neonatal death, or congenital anomaly [including that in an aborted fetus]), the Investigator(s) should follow the procedures for reporting SAEs (i.e., report the event to Celgene S.r.l, by telephone -Tel. +39-02-914343409 and facsimile -Fax +39-02-63471119 or drugsafety-italy@celgene.com- within 24 hours of the Investigator?s knowledge of the event). In the case of a live ?normal? birth, Celgene S.r.l, should be advised by telephone and facsimile within 24 hours of the Investigator?s knowledge of the event. All neonatal deaths that occur within 30 days of birth should be reported, without regard to causality, as SAEs. In addition, any infant death after 30 days that the Investigator(s) suspects is related to the in utero exposure to the study drug should also be reported to Celgene S.r.l, by telephone (Tel. +39-02-91434340) and facsimile
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate toxicity and tolerability of lenalidomide after allografting 2. To evaluate efficacy of lenalidomide in inducing complete remission, defined as negative immunofixation, 12 months after allografting.;Secondary Objective: 1. To evaluate overall-survival 2. To evaluate progression free survival 3. To evaluate event-free survival 4. To evaluate molecular remission rate, and to compare molecular remission rate in patients treated with lenalidomide after tandem auto-allo transplant and after double autologous transplant (study protocol RV-MM-PI-209): molecular remission is defined as the disappearance of the disease- and patient-specific molecular marker by polymerase chain reaction (PCR)-based assay, in both bone marrow and blood on two consecutive tests at least six weeks apart (see Appendix M for details). 5. To monitor minimal residual disease in patients achieving clinical CR with lenalidomide;Primary end point(s): 1. To evaluate toxicity and tolerability of lenalidomide after allografting 2. To evaluate efficacy of lenalidomide in inducing complete remission, defined as negative immunofixation, 12 months after allografting. | — |
Countries
Italy
Outcome results
None listed