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NCT Number: NCT00652041

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Morales Messeguer, Murcia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bortezomib

Drug

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

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

PETHEMA Foundation

Other

Registry information

Official study 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

Acronym: TaCyDexVMP7

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 3, 2008
Registry last updated
Sep 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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