Bortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma
Information source: PETHEMA Foundation
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Bortezomib (Drug); Thalidomide (Drug); Bortezomib (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: PETHEMA Foundation Overall contact:
San Miguel Jesús, Dr, Phone: 923 291 515, Email: ensayosclinicos@husa.sacyl.es
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 Melfalan and Prednisone (V-MP) (patients > 75 years) or Bortezomib and
Adriamycine in combination with Melfalan and Prednisone (VAMP) (patients <= 75 years) follow
by Thalidomide in combination with Cyclophosphamide and Dexamethasone (TaCyDex) in patients
with refractary or relapse multiple myeloma.
Clinical Details
Official title: Thalidomide-Cyclophosphamide-Dexamethasone in Patients < 75 Years or Velcade-Melfalan-Prednisone (V-MP)/Thalidomide-Cyclophosphamide-Dexamethasone in Patients >75 Years, in Refractary or Relapsed Multiple Myeloma
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Efficacy of a sequential scheme treatment with Bortezomib, Melfalan,Prednisone (V-MP) or Bortezomib, Adriamycine, Melfalan,Prednisone (VAMP) followed by Thalidomide, Cyclophosphamide and Dexamethasone (TaCyDex) in relapsed or refractory MM patients
Secondary outcome: Evaluate the response type in function to different initial situation (primary resistance, relapse, progression)To analyze the response duration
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 Melfalan and Prednisone (V-MP) (patients > 75 years) or Bortezomib and
Adriamycine in combination with Melfalan and Prednisone (VAMP) (patients <= 75 years) follow
by Thalidomide in combination with Cyclophosphamide and Dexamethasone (TaCyDex) in patients
with refractary or relapse multiple myeloma.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
San Miguel Jesús, Dr, Phone: 923 291 515, Email: ensayosclinicos@husa.sacyl.es
Hospital Clínico de Salamanca, Salamanca, Spain; Recruiting
San Miguel Jesús, Dr
Mateos Maria Victoria, Dr
Hospital Morales Messeguer, Murcia, Spain; Recruiting
Hospital Virgen de la Vega, Murcia, Spain; Recruiting
Hospital La Fe, Valencia, Spain; Recruiting
Hospital de la Diputación de Navarra, Navarra, Spain; Recruiting
Additional Information
Pethema Foundation web spanish hematology association
Starting date: January 2007
Ending date: June 2010
Last updated: November 26, 2008
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