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

Multiple Myeloma Clinical Trial

— TaCyDexVMP7  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652041
• Other study ID #: TaCyDexVMP7
• Status: Completed
• Phase: Phase 4
• First received: March 31, 2008
• Last updated: September 16, 2011
• Start date: January 2007
• Est. completion date: June 2010

Study information

• Verified date: September 2011
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• 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
• 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
• 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.

Locations

Country	Name	City	State
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluate the response type in function to different initial situation (primary resistance, relapse, progression)		1 year	No
Secondary	To analyze the response duration		2 years	No

External Links

•   spanish hematology association