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| Name | Class |
|---|---|
| Haematology Service, | UNKNOWN |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients are receiving PEG-Intron | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-Intron sc injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Increase of Response (anti-tumoral effect) and Dose Tolerance | Evaluate the anti-tumor efficacy of this maintenance treatment | three years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrián Alegre Amor, Physician Doctor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Principal Investigator |
| José GarcÃa Laraña, Physician | Hospital Ramón y Cajal. Madrid, Spain | Principal Investigator |
| Juan José Lahuerta, Physician Doctor | Hospital 12 de Octubre. Madrid, Spain | Principal Investigator |
| Jesús San Miguel, Physician Doctor | Hospital ClÃnico Universitario. Salamanca, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de La Princesa | Madrid | Madrid | 28006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9753033 | Background | 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. | |
| 11313685 |
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| Background |
| 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. |