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Bortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma (TaCyDexVMP7)

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ClinicalTrials.gov Identifier: NCT00652041
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : September 19, 2011
Sponsor:
Information provided by:
PETHEMA Foundation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Bortezomib Drug: Thalidomide Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : June 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Induction: 6 alternating cycles Bortezomib-Melfalan-Prednisone or Bortezomib- Adriamycine-Melfalan-Prednisone and Thalidomide-Cyclophosphamide-Dexamethasone, followed by other 6 maintenance cycles
 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

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

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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Evaluate the response type in function to different initial situation (primary resistance, relapse, progression) [ Time Frame: 1 year ]
  2. To analyze the response duration [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652041


Locations
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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, Spain
Sponsors and Collaborators
PETHEMA Foundation
More Information
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Additional Information:

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Responsible Party: Pethema
ClinicalTrials.gov Identifier: NCT00652041    
Other Study ID Numbers: TaCyDexVMP7
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: September 19, 2011
Last Verified: September 2011
Keywords provided by PETHEMA Foundation:
Multiple Myeloma
Relapsed
Refractary
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
 Thalidomide
Bortezomib
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors