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

PETHEMA Foundation

Status and phase: Completed; Phase 4

Conditions: Multiple Myeloma

Treatments: Drug: Thalidomide; Drug: Bortezomib

Study type: Interventional

Funder types: Other

Identifiers

NCT00652041

TaCyDexVMP7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

1

Experimental group

Description:

Induction: 6 alternating cycles Bortezomib-Melfalan-Prednisone or Bortezomib- Adriamycine-Melfalan-Prednisone and Thalidomide-Cyclophosphamide-Dexamethasone, followed by other 6 maintenance cycles

Treatment:

Drug: Thalidomide

Drug: Bortezomib

Drug: Bortezomib