GEM05 for Patients With Multiple Myeloma Under 65 Years

Inclusion Criteria:

1. Must be able to comply with the protocol requirements

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

3. Age <65 years and possibly to do an autologous transplant.

4. Patient recently diagnosed with symptomatic Multiple Myeloma who has not received anyprevious chemotherapy treatment for Multiple Myeloma.

5. Patient has a measurable disease defined as quantifiable serum monoclonal proteinvalue and, where applicable, urine Light-chain excretion of ≥ 200 mg/24 hours.

6. ECOG < 2.

7. El patient has a life-expectancy > 3 months.

8. Patient has the following laboratory values before beginning induction treatment:

9. Platelet count ≥ 50000/mm3, hemoglobin ≥ 8 g/dl and absolute neutrophil count ≥ 1000/mm3. Lower values are allowed if they are due to marrow infiltration.

10. Corrected serum calcium <14mg/dl.

11. Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal.

12. Alanine transaminase (ALT): ): ≤ 2.5 x the upper limit of normal.

13. Total bilirubin: ≤1.5 x the upper limit of normal.

14. Serum creatinine ≤ 2 mg/dl.

15. For Patients included in Thalidomide branches: women of childbearing age must not havesex unless they use two anticonceptive methods beginning 4 weeks before the firstdose, during all the study until 4 weeks after the last one.

Exclusion Criteria:

1. Non-secretor Myeloma.

2. Patients previously received treatment to Multiple Myeloma, except steroids doses forurgency or bisphosphonates or radiotherapy before beginning treatment.

3. Patients with < Grade 2 peripheral neuropathy within 14 days before enrolment.

4. Patient had major surgery within 4 weeks before enrolment.

5. Patient has hypersensitivity to bortezomib, boron or mannitol or Thalidomide.

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

7. Patient is known to be seropositive for the human immunodeficiency virus (HIV),Hepatitis B surface antigen-positive or active hepatitis C infection.

8. Patient had a myocardial infarction within 6 months of enrollment or has New YorkHeart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severeuncontrolled ventricular arrhythmias, or electrocardiographic evidence of acuteischemia or active conduction system abnormalities.

9. Patient is enrolled in another clinical research study and/or is receiving aninvestigational agent for any reason.

10. Pregnancy or breast-feed women.