Overview

Bortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
PETHEMA Foundation
Treatments:
BB 1101
Bortezomib
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Melphalan
Prednisone
Thalidomide
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