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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


Phase 4
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome 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

Outcome Time Frame:

1 year

Safety Issue:

No

Authority:

Spain: Ministry of Health

Study ID:

TaCyDexVMP7

NCT ID:

NCT00652041

Start Date:

January 2007

Completion Date:

June 2010

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Relapsed
  • Refractary
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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