Melphalan, Prednisone, and CC-5013 (Revlimid) as Induction Therapy in Multiple Myeloma

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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 those under 65 years who refuse or are not eligible for high dose therapy. This association might further increase the response rate achieved by the standard oral MP regimen.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Turin, Italy
• Treatments: Lenalidomide; Melphalan; Prednisone; Thalidomide

Criteria

Inclusion Criteria:

• 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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 Criteria:

• 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.