Multiple Myeloma
Conditions
Interventions
It is followed by two treatment phases: an induction phase and a maintenance phase. Induction phase: administering any of the schemes used as induction therapy (M + P, VMCP, VAD or other preferably co
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patients over 18 years. 2) Willingness of the individual by signing written consent. 3) Patients with multiple myeloma stage II / III according to Salmon and Durie classification. 4) Patients who have received favorable response to chemotherapy with a minimum of 6 months of treatment.
Exclusion criteria
Exclusion criteria: 1) Pregnancy or lactation. 2) Women of childbearing age who are hormonal contraceptive therapy or have no control over fertility. 3) Hypersensitivity to interferon or other preparations used in the study. 4) Acute or chronic liver (twice the normal value of TGP and TGO and / or total bilirubin > 1.5). 5) Decompensated heart failure. 6) Organic brain disease with symptoms that interfere with patient assessment so as to consent (eg Parkinson disease). 7) Major psychiatric disorder or other constraints that prevent the patient's consent. 8) Autoimmune diseases not related to multiple myeloma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with relapses (Yes, No). Measuring time: at 2 years of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Relapse-free interval (days, months, years). Measuring time: every 3 months to 2 years after initial treatment. - Number of relapses (numeric value). Measuring time: at 2 years of starting treatment. - Survival (alive, dead). Measuring time: at 2 years of starting treatment. - Hematological response (hemoglobin, hematocrit, white blood cell count with differential and platelet count). Measuring time: every 3 months to 2 years after initial treatment. - Proportion of patients developing adverse events (Yes, No). Measuring time: every 3 months to 2 years after initial treatment. - Proportion of patients who develop anti-IFN antibodies (Yes, No). Measuring time: every 3 months to 2 years after initial treatment. | — |
Countries
Cuba
Contacts
Public ContactMSc. Yanelda García Vega
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed