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

NCT ID: NCT00652041

Last Updated: 2011-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2010-06-30

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4 and Prednisone, 60 mg/m2 oral, days 1 to 4

Thalidomide

Intervention Type: DRUG

Thalidomide, day 1 cycle 1, 100 mg/24 h. oral, in combination with cyclophosphamide and dexamethasone. If toxicity is \<Grade 2, dose should be increased to 200 mg/24 h. in day 15

Bortezomib

Intervention Type: DRUG

Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4, Prednisone, 60 mg/m2 oral, days 1 to 4 and Adriamicine, 40 mg/m2 IV day 1 or Caelyx 30 mg/m2 IV day 1.

Interventions

Bortezomib

Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4 and Prednisone, 60 mg/m2 oral, days 1 to 4

Intervention Type: DRUG

Thalidomide

Thalidomide, day 1 cycle 1, 100 mg/24 h. oral, in combination with cyclophosphamide and dexamethasone. If toxicity is \<Grade 2, dose should be increased to 200 mg/24 h. in day 15

Intervention Type: DRUG

Bortezomib

Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4, Prednisone, 60 mg/m2 oral, days 1 to 4 and Adriamicine, 40 mg/m2 IV day 1 or Caelyx 30 mg/m2 IV day 1.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PETHEMA Foundation

OTHER

Sponsor Role: lead

Responsible Party

Pethema

Locations

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

Countries

Spain

Related Links

http://aehh.org

spanish hematology association

Other Identifiers

TaCyDexVMP7

Identifier Type: -

Identifier Source: org_study_id