Status:
COMPLETED
Bortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma
Lead Sponsor:
PETHEMA Foundation
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Multicentric study, open, single arm, designed to evaluate the efficacy(response rate and response duration) and security of a sequential scheme of treatment with Bortezomib in combination with Melfal...
Detailed Description
Multicentric study, open, single arm, designed to evaluate the efficacy(response rate and response duration) and security of a sequential scheme of treatment with Bortezomib in combination with Melfal...
Eligibility Criteria
Inclusion
- Patients with refractary or relapsed multiple myeloma
- ECOG ≤ 3
- Life expectancy \> 3 months
- Neutrophils account ≥ 0.5 X 10\^9/L, platelets ≥ 30 X 10\^9/L.
- Transaminases \<3 times upper normal limit, bilirubin \< 2 times upper normal limit
- Age \> 18 years
- Time after last chemotherapy or radiotherapy \> 1 month or time after transplantation \> 2 months.
- No possible other actual treatment
- Written consent form
Exclusion
- Candidate to second transplantation
- No following criteria
- Other neoplasties
- Peripheral neuropathy \> Grade 2.
- Previous ileus paralytic
- Hepatic failure
- No controlled infection
- No controlled high calcium levels
- Any organic insufficiency that no permit follow the correct treatment
- Pregnancy, breast feeding or fertility without anticonceptive method
- Any psychological, social and/or familiar event that no permit follow the correct treatment
- Diabetes mellitus not controled
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00652041
Start Date
January 1 2007
End Date
June 1 2010
Last Update
September 19 2011
Active Locations (5)
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1
Hospital Morales Messeguer
Murcia, Spain
2
Hospital Virgen de la Vega
Murcia, Spain
3
Hospital de la Diputación de Navarra
Navarra, Spain
4
Hospital Clínico de Salamanca
Salamanca, Spain