Status:
COMPLETED
Melphalan, Prednisone, and CC-5013 (Revlimid) as Induction Therapy in Multiple Myeloma
Lead Sponsor:
University of Turin, Italy
Conditions:
Multiple Myeloma
Eligibility:
All Genders
65+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the association of Melphalan/Prednisone/Revlimid (MPR) as induction treatment for newly diagnosed myeloma patients over age 65 or th...
Detailed Description
In Multiple Myeloma patients, the standard treatment is the oral combination of Melphalan and Prednisone (MP). This approach induces a partial response (PR) rate of approximately 50% and a complete re...
Eligibility Criteria
Inclusion
- Patient is of a legally consenting age as defined by local regulations.
- Age \> 65 years or age \< 65 years in patients who refuse or are not eligible for high-dose therapy.
- Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method)(Highly Effective Methods: Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-; tubal ligation; partner's vasectomy; Additional Effective Methods: Latex condom; Diaphragm; Cervical Cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of Lenalomide therapy - Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of Lenalomide therapy.
- Patient was previously diagnosed with symptomatic multiple myeloma based on standard criteria, and has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine light-chain excretion of \>200 mg/24 hours; measurable plasmacytoma as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan); bone marrow plasma cells \>10%.
- Patient has a Karnofsky performance status ≥ 60%
- Patient has a life-expectancy \> 6 months.
- Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1):
- Absolute neutrophil count \> 1.5 x 109/L without the use of growth factors
- Platelet count \> 75 x 109/L without transfusion support within 7 days before the test.
- Calculated or measured creatinine clearance: ≥ 20 mL/minute
- Total bilirubin \< 1.5 x the ULN
- AST (SGOT) and ALT (SGPT) \< 2.5 x ULN
- Corrected serum calcium ≤ 14 mg/dL (3.5 mmol/L
Exclusion
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or beast feeding females.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other concomitant standard/experimental anti-myeloma drug or therapy.
- Any prior use of CC-5013 or other anti-myeloma therapy.
- Any of the following laboratory abnormalities:
- Platelet count \< 75 x 109/L.
- Absolute neutrophil count \<1.5 x 109/L.
- Calculated or measured creatinine clearance \<20 mL/minute.
- Corrected serum calcium \>14 mg/dL (3.5 mmol/L).
- Aspartate transaminase (AST): \>2.5 x the upper limit of normal (ULN).
- Alanine transaminase (AST): \> 2.5 x the ULN.
- Total bilirubin: \> 1.5 x the ULN.
- Known positive for HIV or active infectious hepatitis, type B or C.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00396045
Start Date
January 1 2005
End Date
January 1 2008
Last Update
November 30 2006
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Unità Operativa di Ematologia, Spedali Civili
Brescia, Brescia, Italy, 25100
2
Reparto di Ematologia, Ospedale Ferrarotto
Catania, Catania, Italy, 95124
3
Unità Operativa Complessa Di Ematologia, Presidio Ospedaliero Dell'Annunziata, Azienda Ospedaliera Di Cosenza
Cosenza, COSENZA, Italy
4
Unità Operativa di Ematologia Trapianto di Cellule Staminali, Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy, 71013