Back to resultsBortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma (TaCyDexVMP7)
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Bortezomib
Thalidomide
Bortezomib
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Relapsed, Refractary
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
Sites / Locations
- Hospital Morales Messeguer
- Hospital Virgen de la Vega
- Hospital de la Diputación de Navarra
- Hospital Clínico de Salamanca
- Hospital La Fe
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Induction: 6 alternating cycles Bortezomib-Melfalan-Prednisone or Bortezomib- Adriamycine-Melfalan-Prednisone and Thalidomide-Cyclophosphamide-Dexamethasone, followed by other 6 maintenance cycles
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Evaluate the response type in function to different initial situation (primary resistance, relapse, progression)
To analyze the response duration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00652041
Brief Title
Bortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
PETHEMA Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Relapsed, Refractary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Induction: 6 alternating cycles Bortezomib-Melfalan-Prednisone or Bortezomib- Adriamycine-Melfalan-Prednisone and Thalidomide-Cyclophosphamide-Dexamethasone, followed by other 6 maintenance cycles
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
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
Intervention Name(s)
Thalidomide
Intervention Description
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
Intervention Name(s)
Bortezomib
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Evaluate the response type in function to different initial situation (primary resistance, relapse, progression)
Time Frame
1 year
Title
To analyze the response duration
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital Morales Messeguer
City
Murcia
Country
Spain
Facility Name
Hospital Virgen de la Vega
City
Murcia
Country
Spain
Facility Name
Hospital de la Diputación de Navarra
City
Navarra
Country
Spain
Facility Name
Hospital Clínico de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://aehh.org
Description
spanish hematology association
Learn more about this trial
Bortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma
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