Maintenance Treatment of Multiple Myeloma (MM) After Autologous Peripheral Blood Transplant (PBSCT) Using Polyethylene Glycol alpha2B Interpheron (PEG-INTRON)
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|ClinicalTrials.gov Identifier: NCT01325896|
Recruitment Status : Unknown
Verified March 2011 by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa.
Recruitment status was: Active, not recruiting
First Posted : March 30, 2011
Last Update Posted : March 31, 2011
- Multiple myeloma accounts for approximately 1% of all cancers and 10% of hematologic malignancies. Between 50 and 70% of symptomatic patients presented response to induction chemotherapy. The rate of complete responses (CR) achieved with standard induction of these treatments is less than 5% of cases and the median event-free survival between 2 and 3 years although most of the patients died from the disease.
- High dose chemotherapy with autologous stem cell transplant has improved the response rate and survival of patient with MM. However eventually all patients relapse with a median EFS between 40-50 months post-transplant.
- To improve these results and sustain remission, various maintenance treatment have been proposed as is the case of Interpheron alpha2b s.c. (Intron A) that has shown benefits in a meta-analysis.
- Intron A s.c. need administration of 3 days per week and is not well tolerated
- Recently a new formulation of Interpheron alpha2b is available. Conjugated with polietilenglicol (Pegintron) that need only one dose weekly and has not been tested in MM.
- The purpose of this study is to evaluate the role of Pegintron as maintenance after autologous transplant in MM
|Condition or disease||Intervention/treatment||Phase|
|Multiple Mieloma||Drug: PEG-Intron sc injection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Maintenance Treatment of Multiple Myeloma (MM) After Autologous Peripheral Blood Transplant (PBSCT) Using Polyethylene Glycol alpha2B Interpheron (PEG-INTRON)|
|Study Start Date :||September 2002|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||March 2012|
|All patients are receiving PEG-Intron||
Drug: PEG-Intron sc injection
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.
- Time to Progression (TTP) and WHO (World Health Organization) Toxicity scale [ Time Frame: three years ]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.
- Increase of Response (anti-tumoral effect) and Dose Tolerance [ Time Frame: three years ]Evaluate the anti-tumor efficacy of this maintenance treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325896
|Hospital Universitario de La Princesa|
|Madrid, Spain, 28006|
|Principal Investigator:||Adrián Alegre Amor, Physician Doctor||Hospital Universitario de La Princesa (Madrid, Spain)|
|Principal Investigator:||José García 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 Clínico Universitario. Salamanca, Spain|