Treatment With a Scheme With Low Doses of Bortezomib / Melphalan / Prednisone (MPV) in Patients With Multiple Myeloma
Status:
Terminated
Trial end date:
2018-07-01
Target enrollment:
Participant gender:
Summary
This clinical trial is a multicenter, cohort, with one arm to study the SLP to 18 months of
Velcadito scheme (velcade 1.0 mg / m2 administered over two days with melphalan and
prednisone) in patients with MM diagnosis again higher 75. After completion of the protocol
patients were still approximately every two months, in clinical practice, to observe the
survival and answers to other treatments. All the scans are part of the normal routine. The
realization of diagnostic tests and drug treatment will be performed regardless of the
patient's participation in the study as part of routine clinical practice All patients who
meet criteria. The incidence of MM age-adjusted to cover the participating hospitals is
estimated in 44 patients.
Patients will receive a course of 4 weeks duration of Melphalan / Prednisone / Velcade
consist in Melphalan, 9 mg / m2 orally daily 1-4 and Prednisone 60 mg / m2 orally on days 1
to 4, in combination Velcade with a dose of 1.3 mg / m2 sc twice weekly (days 1, 4, 8, 11),
followed by 2 weeks of rest (cycle duration of 4 weeks) and seven four-week cycles duration
of melphalan / prednisone / Velcade consist in Melphalan, 9 mg / m2 orally on days 1 to 4 and
prednisone, 60 mg / m2 orally on days 1 to 4, in combination with Velcade, at doses of 1, 0
mg / m2 sc (days 1, 4).
Melphalan and Prednisone will be dispensed for oral administration. The Melphalan should be
administered in a single two hours separately taking any food and prednisone be taken in the
morning with or immediately after a meal. The amount in mg will be calculated based on the
body surface, to be calculated on day 1 of each cycle. Velcade for administration, calculated
on day 1 of the cycle will be the same dose throughout the entire cycle. If a patient
experiences a gain or loss of remarkable weight within the cycle, the dose to be administered
will be recalculated based on the new body surface. The appropriate amount of Velcadeserá
dispensed in a sc injection. Velcade dose between two leave at least 72 hours