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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00652041

Acronym

TaCyDexVMP7

Enrollment

Registered

2008-04-03

Start date

2007-01-31

Completion date

2010-06-30

Last updated

2011-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, Relapsed, Refractary

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

Interventions

DRUGBortezomib

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

DRUGThalidomide

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026