Maintenance Treatment of Multiple Myeloma (MM) After Autologous Peripheral Blood Transplant (PBSCT) Using Polyethylene Glycol alpha2B Interpheron (PEG-INTRON)

NCT01325896 | Unknown Phase 2

• 1 other identifier: PI-MM-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

• 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

Conditions

Multiple Mieloma

Keywords

Multiple Mieloma, PEG-Intron

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Increase of Response (anti-tumoral effect) and Dose Tolerance

  three years

Study Arms (1)

All patients are receiving PEG-Intron

OTHER

Drug: PEG-Intron sc injection

Interventions

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.

All patients are receiving PEG-Intron

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≤ 65 years old diagnosed with multiple myeloma in stage II or III of Durie-Salmon staging.
• Patients who have achieved a complete response, partial after a myelosuppressive chemotherapy treatment followed by infusion of peripheral blood progenitor cells as first-line treatment. The criteria used to define the complete or partial response are the EBMT, ABMTR IBMTR and set out in the criteria paper of Bladé J, Samson D, Reece D, et al 1998
• Subjects must have a Karnofsky performance status ≥ 60% at the time of joining the program.
• Subjects must have adequate renal and hepatic function, defined as \<2 times the upper limit of normal laboratory.
• Subjects must have adequate hematologic function, defined as: platelets\> 50,000/μl, ≥Hemoglobin 9.0 g/dl, total leukocyte account\> 2.000/μl
• No history of any cancer within the past 5 years except squamous cell carcinoma or basal cell skin or cervical carcinoma in stage I or in situ.
• No history of hypersensitivity to interferon alfa or any other part of the injection.
• No severe clotting disorders, thrombophlebitis or pulmonary embolism, or decompensated liver disease.
• Pregnant or lactating at the time of diagnosis can not participate in this therapeutic program. During the same, men and women participants should not conceive children. Also, women who become pregnant will be withdrawn from the protocol.
• Obtaining informed consent.

You may not qualify if:

• Patients \> 65 years old.
• Patients with multiple myeloma stage I of Durie-Salmon staging system.
• Patients who have not achieved a complete or partial response after a myelosuppressive chemotherapy regimen followed by infusion of progenitor cells from peripheral blood autologous treatment of any kind is allowed intensification of chemotherapy and pretransplant conditioning regimen. The criteria used to define the complete or partial response are the EBMT, ABMTR IBMTR and set out in the criteria paper of Bladé J, Samson D, Reece D, et al 1998
• Treatment with any investigational drug within 30 days prior to the addition to this protocol.
• Subjects with severe cardiovascular disease.
• Subjects with a history of neuropsychiatric disorder that requires hospitalization.
• Subjects with thyroid dysfunction or uncontrolled diabetes mellitus (refractory to treatment).
• Subjects with active infection and / or uncontrolled.
• Pregnant or lactating women or women of childbearing age not practicing effective contraception.
• Patients with previous psychiatric disease, especially moderate or severe depression or a history of severe psychiatric disorder, including psychosis, suicidal thoughts or suicide attempts. In severe depression cover the following points: (a) hospitalization for depression (b) electroconvulsive therapy for depression or (c) depression leading to the prolonged absence at work or to alter significantly the daily functions. Can be consider the entrance into the study of subjects with mild depression, where it is demonstrated by pre-treatment assessment individual's emotional state is clinically stable and in which case a treatment program formulated for the patient who will become part of the patient's medical record.

Sponsors & Collaborators

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: lead
• Haematology Service,: collaborator

Study Sites (1)

Hospital Universitario de La Princesa

Madrid, Madrid, 28006, Spain

Location

Related Publications (2)

• 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.

  PMID: 9753033 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.

  PMID: 11313685 BACKGROUND

Study Officials

• Adrián Alegre Amor, Physician Doctor

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 30, 2011
• Study Start: September 1, 2002
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 31, 2011

Record last verified: 2011-03

Locations

ES (1)