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

March 30, 2011 updated by: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
  • 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase of Response (anti-tumoral effect) and Dose Tolerance
Time Frame: three years
Evaluate the anti-tumor efficacy of this maintenance treatment
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Collaborators

Haematology Service,

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (ANTICIPATED)

March 1, 2012

Study Completion (ANTICIPATED)

March 1, 2012

Study Registration Dates

First Submitted

March 11, 2011

First Submitted That Met QC Criteria

March 29, 2011

First Posted (ESTIMATE)

March 30, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2011

Last Update Submitted That Met QC Criteria

March 30, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-MM-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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