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