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Multiple MielomaPhase 2NCT01325896

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

A Phase 2 study testing PEG-Intron sc injection in people with Multiple Mieloma, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Mieloma
What is being tested?
PEG-Intron sc injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteSpain
Study dates
Sep 2002to Mar 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario de La Princesa

    Madrid, Madrid, 28006

Other trials in Spain

About this study

  • 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
Being tested
PEG-Intron sc injection
Keywords
Multiple Mieloma, PEG-Intron

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEG-Intron sc injectionDrug

    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.

Study groups in NCT01325896
Study groupRoleWhat they receive
All patients are receiving PEG-IntronOtherNot described
Receives: Drug: PEG-Intron sc injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: three years

Secondary outcomes (1)

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

    Evaluate the anti-tumor efficacy of this maintenance treatment

    Measured: three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2011 (estimated)
  2. Study startSep 2002
  3. Primary completionMar 2012 (estimated)
  4. Study completionMar 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01325896
Sponsor's protocol ID
PI-MM-01
Status last verified
Mar 2011
First submitted
11 Mar 2011
Last updated
31 Mar 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 9753033

  • 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.

    PubMed 11313685

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PEG-Intron sc injection in people with Multiple Mieloma, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Progression (TTP) and WHO (World Health Organization) Toxicity scale (time frame: three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01325896, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2011.

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