Pethema Multiple Myeloma 2000

Multiple Myeloma Clinical Trial

Official title:

Multiple Myeloma 2000. Multicentric Evaluation of a Therapeutic Strategy Optimized in Multiple Myeloma. Analysis of Efficiency and Possible Pronostic Impact of Minimal Residual Disease (Measured By PCR And Citometry of Flow) in Patients With Complete Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560053
• Other study ID #: PETHEMA MM-2000
• Status: Completed
• Phase: Phase 3
• First received: November 15, 2007
• Last updated: November 26, 2008
• Start date: January 2000
• Est. completion date: February 2005

Study information

• Verified date: November 2008
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The study objectives are to investigate the toxicity and the BUMEL response rate; in patients who reach the CR after autotransplantation, investigate if negativization of IF, influences in disease evolution; in patients in PR after autotransplantation, analyze if the second intensive procedure is capable of increasing the response rate and increasing the survival so that patients who reached the CR with the first transplantation; Patients with MM primarily resistant to the chemotherapy, investigate the efficacy of a double transplantation; patients submitted to double transplantation, control the efficacy of the second transplantation in front of allogenic transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 69 Years

Eligibility

Inclusion Criteria:

• Less 70 years

• ECOG 0-2

• Symptomatic MM (pain, anemia, infection, haemorrhage, loss of weight, hypercalcemia, extramedulary plasmocytoma, creatinine >2 mg/dl).

• No previous chemotherapy

Exclusion Criteria:

• >70 years

• ECOG 3-4

• myeloma quiescent

• cardiopathy

• liver disfunction

• HIV+

• Hepatitis B-C +

• Previous chemotherapy

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Alternating chemotherapy
4 cycles of alternating chemotherapy VBMCP/VBAD (every 5 weeks). VBMCP: Vcr 2 mg ev day 1, BCNU 0.5 mg/kg ev day 1, Cyclophosphamide 10 mg/kg day 1, Melphalan 0.25 mg/kg v.o. days 1-4, Prednisone 1 mg/kg v.o. days 1-4, 0.5 mg/kg days 5-8 and 0.25 mg/kg days 9-12. VBAD: Vcr 1 mg e.v. day 1, BCNU 30 mg/m 2 e.v. day 1, Adriamycine 40 mg/m 2 day 1, Dexamethasone 40 mg/m 2 days 1-4, 9-12 and 17-20.

Procedure:
• Autologous Transplantation
Autologous Transplantation : BUMEL:Busulfan, total dose 12 mg/kg (days -6 a -3; prophylaxis with difenilhidantoine) Melphalan 140 mg/m 2 , ev day -2 TASPE: To investigator criteria

Drug:
• Maintenance
At 3 months of transplantation or with >1.500 neutrophiles/ > 75.000 platelets mm 3 . Prednisone: 50 mg alternating days during 2 years Interferon alfa 2-b: 3 M UI s.c. Three times a week until relapse.

Procedure:
• Second transplantation
In cases that no reach CR with BUMEL is programmed second transplantation, after 4-8 months .
• ALOGENIC MINI TRASPLANTATION
ALOGENIC MINI TRASPLANTATION Fludarabine 30 mg / m 2 / day, days -7, -6, -5, -4, -3 Melphalan 70 mg / m 2 / day, day -2 Prophylaxis EICH: CsA + MTX or CsA + MOFETIL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

External Links

•   spanish hematology association