NCT01325896|UnknownPhase 2
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Sponsor study identifier
interventional
33
1 country
1
Study Start
September 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2002
Date type not reportedThis date has not been verified as actual or estimated.
March 11, 2011
Actual (reported)March 30, 2011
Actual (reported)March 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Time to Progression (TTP) and WHO (World Health Organization) Toxicity scale
Evaluate the number of Participants with Adverse Events, and provide guidelines for treatment with PEG-Intron (either in association with corticosteroids and / or bisphosphonate), administered weekly to patients with multiple myeloma who have achieved a complete or partial response after a myelosuppressive chemotherapy regimen, followed by an infusion of autologous peripheral blood progenitor cell (PBSCT) as treatment intensification.
three years
Increase of Response (anti-tumoral effect) and Dose Tolerance
three years
This program is only open to patients with multiple myeloma who have achieved a complete or partial response after a myelosuppressive chemotherapy regimen followed by autologous stem cell infusion of peripheral blood transplant (PBSCT) as treatment intensification. These patients will be treated with PEG-Intron as maintenance therapy, to be permitted during the same concomitant administration of corticosteroids and / or bisphosphonates. PEG-Intron: 35 mcg per week by subcutaneous injection to progression or recurrence of the disease, or for 5 years maximum. Patients were administered PEG-Intron to a uniform dose of 15 mg initial week for 2 weeks. If this dose is tolerated, it would be gradually increased to 25 mg and then to 35 mg every 2 weeks, assuming that there is no toxicity of grade 3 or worse.
Hospital Universitario de La Princesa
Madrid, Madrid, 28006, Spain
Blade J, Samson D, Reece D, Apperley J, Bjorkstrand B, Gahrton G, Gertz M, Giralt S, Jagannath S, Vesole D. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant. Br J Haematol. 1998 Sep;102(5):1115-23. doi: 10.1046/j.1365-2141.1998.00930.x. No abstract available.
Bjorkstrand B, Svensson H, Goldschmidt H, Ljungman P, Apperley J, Mandelli F, Marcus R, Boogaerts M, Alegre A, Remes K, Cornelissen JJ, Blade J, Lenhoff S, Iriondo A, Carlson K, Volin L, Littlewood T, Goldstone AH, San Miguel J, Schattenberg A, Gahrton G. Alpha-interferon maintenance treatment is associated with improved survival after high-dose treatment and autologous stem cell transplantation in patients with multiple myeloma: a retrospective registry study from the European Group for Blood and Marrow Transplantation (EBMT). Bone Marrow Transplant. 2001 Mar;27(5):511-5. doi: 10.1038/sj.bmt.1702826.
Adrián Alegre Amor, Physician Doctor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
José García Laraña, Physician
Hospital Ramón y Cajal. Madrid, Spain
Juan José Lahuerta, Physician Doctor
Hospital 12 de Octubre. Madrid, Spain
Jesús San Miguel, Physician Doctor
Hospital Clínico Universitario. Salamanca, Spain
First Submitted
March 11, 2011
First Posted
March 30, 2011
Study Start
September 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2012
Estimated (date passed)Real-World Patterns of Utilization of Lenalidomide-based Triplet Regimens in FIrst RElapsed Multiple Myeloma Patients: Evidence From Medical Record Review
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 31, 2011
Record last verified: 2011-03
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