Multiple Mieloma Clinical Trial
Official title:
Maintenance Treatment of Multiple Myeloma (MM) After Autologous Peripheral Blood Transplant (PBSCT) Using Polyethylene Glycol alpha2B Interpheron (PEG-INTRON)
- 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
| Status | Active, not recruiting |
| Enrollment | 33 |
| Est. completion date | March 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario de La Princesa | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Universitario de la Princesa | Haematology Service, |
Spain,
Björkstrand B, Svensson H, Goldschmidt H, Ljungman P, Apperley J, Mandelli F, Marcus R, Boogaerts M, Alegre A, Remes K, Cornelissen JJ, Bladé 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. — View Citation
Bladé J, Samson D, Reece D, Apperley J, Björkstrand 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | Increase of Response (anti-tumoral effect) and Dose Tolerance | Evaluate the anti-tumor efficacy of this maintenance treatment | three years | No |