GEM05 for Patients With Multiple Myeloma Under 65 Years
GEM05 for Patients With Multiple Myeloma Under 65 Years
The primary objective is to compare safety and efficacy of three induction treatments:
 VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide /
 Dexamethasone. The second one is to evaluate the ability of stem cell mobilization after the
 treatments in order to do an autologous transplant. Otherwise this study wants to compare the
 safety and efficacy of the maintenance treatments: Interferón a-2b versus Thalidomide versus
 Thalidomide/Velcade.
A total of up to 390 patients ≤ 65 years old diagnosed of Multiple Myeloma with symptomatic
 disease and that have not received previous chemotherapy for MM will be included.

 Patients will be evaluated at scheduled visits in up to three study periods: Pre-treatment,
 Treatment and Follow up.

 The Pre-treatment includes Screening and baseline visits. After providing informed consent,
 patients will be evaluated for study eligibility and then Patients will be randomized (1:1:1)
 to receive VBMCP-VBAD+Velcade (Group A) or Thalidomide+Dexamethasone (Group B) or
 Thalidomide+Dexamethasone+Velcade (Group C). All of them will received the induction
 treatment up to 24 weeks.

 After 4 weeks, without progression or unacceptable toxicity, There will be stem cell
 mobilization to do an autologous transplant. Three months after transplant, patients will be
 again randomized (1:1:1) to receive maintenance treatment: Interferon-a (Group M1) or
 Thalidomide (Group M2) or Thalidomide+Velcade (Group M3) during three years.

 Once the treatment period has finished a follow up will be carry out. During this period we
 will evaluated response, progression-free survival and global survival every three months.
Inclusion Criteria:

 1. Must be able to comply with the protocol requirements

 2. Must voluntary sign the informed consent before performance of any study-related
 procedure 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 any
 previous chemotherapy treatment for Multiple Myeloma.

 5. Patient has a measurable disease defined as quantifiable serum monoclonal protein
 value 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:

 1. 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.

 2. Corrected serum calcium <14mg/dl.

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

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

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

 6. Serum creatinine ≤ 2 mg/dl.

 9. For Patients included in Thalidomide branches: women of childbearing age must not have
 sex unless they use two anticonceptive methods beginning 4 weeks before the first
 dose, 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 for
 urgency 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 York
 Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
 uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
 ischemia or active conduction system abnormalities.

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

 10. Pregnancy or breast-feed women.