Randomized Trial Comparing Lenalidomide With Low Dose Dexamethasone Versus Lenalidomide in Second Line Multiple Myeloma

Inclusion criteria

Inclusion criteria

- all subjects must:

• Be at least 18 years of age
• Subjects must have a documented diagnosis of MM and have either refractory or relapsed and refractory after first line treatment disease defined as:

• Primary refractory
• Refractory
• Relapsed and Refractory
• Subjects must have undergone prior treatment with one treatment line of anti-myeloma therapy. Induction therapy followed by ASCT and consolidation/maintenance will be considered as one line.Have a confirmed diagnosis of MM
• Have received lenalidomide after one prior treatment for MM and have reached at least a partial response (PR), according to IMWG criteria, including two consolidating cycles. Subjects have experienced a response at least PR after starting treatment with lenalidomide and cortisone cycles.
• Have personally signed and dated a legally effective written informed consent form prior to admission to the study.
• Must be willing and able to understand and comply with the study requirements.
• Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception.
• Male must agree to practice contraception

Exclusion criteria

• Any of the following laboratory abnormalities:

• Absolute neutrophil count (ANC) < 1,000/µL
• Platelet count < 75,000/ µL
• Creatinine Clearance < 45 mL/min according to Cockcroft-Gault formula
• Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
• Serum total bilirubin > 2.0 mg/dL
• ECOG performance status <4.
• Individuals who have had a stem-cell transplant as a 2nd line treatment for MM
• Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening.
• Individuals with significant psychiatric illness or a clinically significant acute/chronic uncontrolled medical condition that might affect their experience of myeloma symptoms or their ability to describe them.
• Pregnant or lactating females.
• Any other clinically significant medical disease or condition that, in the Investigator´s opinion, may interfere with protocol adherence or a subject´s ability to give informed consent.