Clinical trial NCT00652041: Bortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Relapsed
Refractary
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2008-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: Evaluate the response type in function to different initial situation (primary resistance, relapse, progression)
timeFrame: 1 year
measure: To analyze the response duration
timeFrame: 2 years
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Morales Messeguer
city: Murcia
country: Spain
facility: Hospital Virgen de la Vega
city: Navarra
country: Spain
facility: Hospital de la Diputación de Navarra
city: Salamanca
country: Spain
facility: Hospital Clínico de Salamanca
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
References: