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

Phase 4

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Bortezomib; Drug: Thalidomide

• Registration Number: NCT00652041
• Lead Sponsor: PETHEMA Foundation

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 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.

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-03
• Primary Completion: 2010-01
• Study Completion: 2010-06
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-16
• Last Update Posted: 2011-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Bortezomib	Induction: 6 alternating cycles Bortezomib-Melfalan-Prednisone or Bortezomib- Adriamycine-Melfalan-Prednisone and Thalidomide-Cyclophosphamide-Dexamethasone, followed by other 6 maintenance cycles
1	Thalidomide	Induction: 6 alternating cycles Bortezomib-Melfalan-Prednisone or Bortezomib- Adriamycine-Melfalan-Prednisone and Thalidomide-Cyclophosphamide-Dexamethasone, followed by other 6 maintenance cycles

Primary Outcome Measures

Name	Time	Method
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	1 year

Secondary Outcome Measures

Name	Time	Method
Evaluate the response type in function to different initial situation (primary resistance, relapse, progression)	1 year
To analyze the response duration	2 years

Trial Locations

Locations (5)

Hospital Morales Messeguer; 🇪🇸 Murcia, Spain

Hospital Virgen de la Vega; 🇪🇸 Murcia, Spain

Hospital de la Diputación de Navarra; 🇪🇸 Navarra, Spain

Hospital Clínico de Salamanca; 🇪🇸 Salamanca, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain