GEM05 for Patients With Multiple Myeloma Under 65 Years

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PETHEMA Foundation
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Thalidomide; Vincristine

Criteria

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.