QUIREDEX: Revlimid (Lenalidomide) and Dexamethasone (ReDex) Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression

Inclusion Criteria:

• Must be able to comply with the protocol requirements

• Must voluntary sign the informed consent before performance of any study-relatedprocedure not part of normal medical care

• Age ≥ 18 years

• Patient recently diagnosed with smoldering Multiple Myeloma with high risk ofprogression to symptomatic Multiple Myeloma defined as follows:

• Bone Marrow infiltration ≥ 10% CPs and M component Ig G ≥ 3 g/dl or Ig A ≥ 2 g/dlor Bence Jones Protein > 1 g/dl and absence of: hollowed out areas of bone,Hypercalcemia (Calcium-serum < 11.5 mg/dl), Renal Failure (creatinine < 2 mg/dl)and anaemia (Hb > 10 g/dl or at least 2g/dl under normal value.

• Alternatively, patients with Bone Marrow infiltration with CPs ≥ 10 %, or Ig G ≥ 3 g/dl or Ig A ≥ 2 g/dl or Bence Jones Protein > 1 g/24h (but not the two of themtogether) and always without: lytic lesions, Hypercalcaemia, Renal Failure andAnaemia could be admitted with the following additional criteria:

• % CPs abnormal (CPa/CpcMO) ≥ 95 % with immunodeficiency, defined asdiminution of levels of one or two Immunoglobulins of more than 25% respectnormal values.

• ECOG >= 2.

• The patient has to be able to complain with the protocol visits.

• Women of childbearing age must have a negative pregnancy test during the 14 daysbefore first dose. And they must accept to use anticonceptive methods beginning duringall the study until 4 weeks after the last one.

Exclusion Criteria:

• Any other organic or mental illness that could make impossible to sign the Informconsent.

• Patients previously received treatment to smoldering Multiple Myeloma.

• Pregnancy or breast-feed women

• Hollowed out areas of bone, anaemia, renal failure and Hypercalcemia

• The following laboratory data:

• Absolute neutrophil count ≥ 1000/mm3

• Platelet count ≥ 75000/mm3

• Aspartate transaminase (AST) or Alanine transaminase (ALT ) ≤ 3 x the upper limitof normal.

• Total bilirubin: ≤ 2 x the upper limit of normal.

• Patients with >= Grade 2 peripheral neuropathy within 14 days before enrolment.

• Patient with a previous clinical history of another malignant illness except forsquamous cell carcinoma or skin cancer or cervical cancer except the patient could befree of symptoms during ≥ 5 years.

• Patient has hypersensitivity or adverse events previous to lenalidomide orDexamethasone.

• Patient who has major surgery during the 4th weeks previous inclusion.

• Patient has received other investigational drugs within 30 days before enrolment.