Status:
COMPLETED
GEM05 for Patients With Multiple Myeloma Under 65 Years
Lead Sponsor:
PETHEMA Foundation
Conditions:
Multiple Myeloma
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
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 evaluate...
Eligibility Criteria
Inclusion
- Must be able to comply with the protocol requirements
- Must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care,
- Age \<65 years and possibly to do an autologous transplant.
- Patient recently diagnosed with symptomatic Multiple Myeloma who has not received any previous chemotherapy treatment for Multiple Myeloma.
- Patient has a measurable disease defined as quantifiable serum monoclonal protein value and, where applicable, urine Light-chain excretion of ≥ 200 mg/24 hours.
- ECOG \< 2.
- El patient has a life-expectancy \> 3 months.
- Patient has the following laboratory values before beginning induction treatment:
- 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.
- Corrected serum calcium \<14mg/dl.
- Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal.
- Alanine transaminase (ALT): ): ≤ 2.5 x the upper limit of normal.
- Total bilirubin: ≤1.5 x the upper limit of normal.
- Serum creatinine ≤ 2 mg/dl.
- 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
- Non-secretor Myeloma.
- Patients previously received treatment to Multiple Myeloma, except steroids doses for urgency or bisphosphonates or radiotherapy before beginning treatment.
- Patients with \< Grade 2 peripheral neuropathy within 14 days before enrolment.
- Patient had major surgery within 4 weeks before enrolment.
- Patient has hypersensitivity to bortezomib, boron or mannitol or Thalidomide.
- Patient has received other investigational drugs within 30 days before enrolment.
- Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection.
- 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.
- Patient is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.
- Pregnancy or breast-feed women.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00461747
Start Date
March 1 2006
End Date
December 1 2008
Last Update
September 18 2009
Active Locations (79)
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1
Hospital General de Alicante
Alicante, Alicante, Spain
2
Hospital Royo Villanova
Zaragoza, Aragon, Spain
3
Hospital Ntra. Sra. Sonsoles
Ávila, Avila, Spain
4
Xarxa assistencial de Manresa
Manresa, Barcelona, Spain