Refractory multiple myeloma.
Conditions
Interventions
Trade Name: Imnovid
Pharmaceutical Form: Tablet
INN or Proposed INN: POMALIDOMIDE
CAS Number: 19171-19-8
Other descriptive name: POMALID
Sponsors
Fundación para la investigación biomédica de Córdoba
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject older than 18 years meeting criterion 2 or 3. 2. Subject diagnosed of multiple myeloma. 3. Patients with symptomatic multiple myeloma relapsed / refractory after receiving at least two treatment cycles including Bortezomib and at least two cycles that include Lenalidomide, combined in the same therapeutic regimen or as part of different chemotherapy regimens. a) Clinical and / or biological relapse : Patients must have received at least two prior lines of treatment and have relapsed after obtaining at least stable disease for at least one cycle of each of the chemotherapy regimens received before they developed progression of the disease. i. Clinical relapse: Defined according to the International Myeloma Working Group (IMWG) criteria. ii. Biological Relapse y: They are defined according to the International Myeloma Working Group (IMWG) criteria. b) Refractory disease: In this case, patients should have progressed on a processing line or within 60 days after completion before inclusion. 4. Patients with multiple myeloma with measurable disease, defined as the presence of monoclonal component of at least 0.5 g / dL in serum or at least 0.2 g / d in urine, or in those without measurable disease radio presence altered light chain at the time of study entry. 5. Patients with good performance status ECOG defined as ? 2. 6. Signature of informed consent. 7. The patient should be able to meet all scheduled visits and other requirements. 8. Laboratory analysis: Patients must have: a) absolute neutrophil: ?1000 / uL b) Platelet Count: ?50.000 / uL c) Hemoglobin:> 8 g ??/ dL d) Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Any concomitant diseases, abnormal laboratory or psychiatric disorder that can assume inability of the subject to sign the IC. 2. PS> 3 on the ECOG scale. 3. Previous history of non-hematologic neoplasia, unless the patient has been free of the disease for ? 5 years. Exceptions include the following: a. basal cell skin carcinoma b. squamous cell skin carcinoma c. In situ cervical carcinoma d. In situ breast carcinoma 4. Patients who are unable or unwilling to undergo an antithrombotic therapy. 5. Positive serology known for HIV or HIV active infectious hepatitis, type B, or C. 6. Depressed cardiac function or clinically significant cardiac disease 7. Severe hypercalcemia 8. Major surgery within 15 days prior to the inclusion or not having recovered from its side effects. 9. Any serious medical condition, including laboratory abnormalities that make the patient to take an unacceptable risk if he participates in this study or that may interfere with the interpretation of the trial data. 10. Patients treated with any investigational drug within the previous 28 days. 11. Any severe medical condition, abnormality in laboratory tests or any psychiatric illness that prevented the signing of written consent. 12. Pregnant women or breast-feeding. 13. Hypersensitivity to drugs or compounds or biological composition similar to study chemistry. 14. Plasma Cell Leukemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the overall response rate based on the criterion of the International Myeloma Working Group (IMWG) considering the best response obtained.; Secondary Objective: Time to response, duration of response, time to progression, overall survival, progression free survival. Tolerability and toxicity of the treatment schedule Studies of biological markers of activity of metronomic chemotherapy ; Primary end point(s): Based on the International Myeloma Working Group (IMWG): Strict Complete response (SCR) Complete response (CR) Partial, very good response (VGPR) Partial response (PR) Minor response (MR) ;Timepoint(s) of evaluation of this end point: After every cycle or during the maintenance period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall survival: Since the entry into the study or treatment initiation to date of the patient's death or the last date knowledge that the patient was alive. - Time to progression: Since the entry into the study or treatment initiation to progression or recurrence of the disease. Progression-free survival: Since the entry into the study or treatment initiation to progression or recurrence of the disease (including death due to myeloma). - Free survival events: Since the entry into the study or treatment initiation to progression or recurrence of the disease (including death due to any cause). - Start of response: Since the entry into the study or treatment initiation to response. Relapse-free time: Since the end of treatment until progression or recurrence of the disease. - Duration of response: Since the answer to progression or recurrence of the disease. - Disease-free survival and recurrence-free survival: Since the answer to progression or recurrence of the disease, but measured only in patients who achieved complete remission or unconfirmed complete remission. Tolerability and toxicity of treatment: number of adverse events attributable to the study medication, assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE 4.0). Biological marker studies of metronomic chemotherapy activity: Angiogenesis markers: Assessments of circulating endothelial cells by CFM and serum levels of VEGF, TSP-1. Evaluation of the immune system: Determination of regulatory T cells populations. ;Timepoint(s) of evaluation of this end point: In every visit. | — |
Countries
Spain
Contacts
Public ContactAntonio Luque
Fundación para la investigación biomédica de Córdoba
Outcome results
None listed