Clinical trial with a pharmaceutical specialty in a new combination. Pomalidomide in combination with dexamethasone is indicated in the treatment of adult patients with multiple treatment-resistant or relapsing myeloma who have received at least two previous treatments, including lenalidomide and bortezomib, and who have experienced a disease progression in the last treatment. The combination of Pomalidomide with Cyclophosphamide at metronomic doses (Very low doses) and Dexamethasone is tested in this clinical situation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Treatment Phase: Combination of Pomalidomide, Cyclophosphamide and Dexamethasone, days 1-21 every 4 weeks (28 day cycles), up to a total of 8 cycles: * Pomalidomide: Treatment with Pomalidomide 4 mg / day 1-21 days in 28-day cycles is started. Dose reductions will be made based on the evaluation of hematological and non-hematological toxicity. * Cyclophosphamide: Cyclophosphamide will be administered 15 mg / day, days 1-28 in 28-day cycles. * Dexamethasone: Dexamethasone will be administered 40 mg / day, days 1, 8, 15 and 22 in 28-day cycles. In patients older than 75 years the dose will be reduced to 20 mg / day in the same previous schedule. Maintenance Phase: Combination of Pomalidomide and Dexamethasone. The last doses prescribed in the previous cycle will be maintained.
Hospital Universitario Reina Sofía
Córdoba, Spain
Best response
Evaluate the best response rate based on the criteria of the International Myeloma Working Group of the following responses at the end of each cycle or during the maintenance period.
Time frame: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Time to Response
From the entry into the study or the start of treatment until the first evidence of a confirmed response.
Time frame: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Duration of Response
Time from the first evidence of response to the progression or recurrence of the disease.
Time frame: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Time to Progression
From the entry into the study or the start of treatment to the progression or recurrence of the disease.
Time frame: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Global Survival
from the entry into the study or the start of treatment until the date of death of the patient or the last date on which it was known that the patient was alive.
Time frame: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Progression Free Survival
from the entry into the study or the start of treatment to the progression or recurrence of the disease (includes death from myeloma)
Time frame: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Tolerability of the study medication
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.
Time frame: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Angiogenesis markers of metronomic chemotherapy activity
Evaluations of treatment of Circulating Endothelial Cells by multiparameter flow cytometry.
Time frame: At baseline and before the beginning of the 2nd, 4th, 6th and 8th treatment cycle (each cycle is 28 days)
Angiogenesis markers of metronomic chemotherapy activity 2
Evaluations of treatment of Circulating Endothelial Cells by serum levels of VEGF, TSP1.
Time frame: At baseline and before the beginning of the 2nd, 4th, 6th and 8th treatment cycle (each cycle is 28 days)
Immune system evaluation of metronomic chemotherapy activity
Evaluation of the Immune system by the determination of regulatory T populations.
Time frame: At baseline and before the beginning of the 2nd, 4th, 6th and 8th treatment cycle (each cycle is 28 days)
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