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More info
You can access this
clinical trial
if you have
Multiple Myeloma
and you are
over 18
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

Overview of Study Design: This is an open phase II, single-arm, multi-center study to evaluate progression free survival in patients receiving ixazomib in combination with thalidomide and dexamethasone (ITD) followed by an ixazomib maintenance phase of a maximum period of 12 months. The patient population will consist of adult male and female patients with multiple myeloma (MM) with relapsed and/or refractory disease after at least one prior treatment line. In case of enrollment patients will receive ixazomib 4.0mg at days 1, 8, 15, thalidomide 100mg at days 1 to 28 (50mg in patients aged ≥75 years), and dexamethasone 40mg (20mg in patients aged ≥75 years) at days 1, 8, 15 of a 28-day treatment cycle. The proposed number of cycles is 8. Treatment will be discontinued in case of progressive disease or in case of no response after 4 cycles (≤ SD after 4 cycles). After discontinuation of therapy an end of treatment visit (EOT) will be performed within 14 days after the last dose of the last combination treatment cycle. After 8 cycles of ITD therapy, maintenance treatment with 4.0mg ixazomib (3.0mg in patients aged ≥ 75 years at first day of maintenance phase) on days 1, 8, 15 of 28-day cycles will be administered to patients with ≥ MR for a maximum period of 12 months. Patients who completed less than 8 cycles of ITD treatment do not qualify for maintenance phase. Follow-up visits will be performed in 3-monthly intervals until the last patient on ixazomib maintenance therapy has concluded or discontinued the maintenance phase. A safety analysis will be conducted after enrollment of the first 6 patients and completion of at least two cycles in every patient.

Provided treatments

  • Drug: Ixazomib
  • Drug: Thalidomide
  • Drug: Dexamethasone
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Locations near you

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Tris trial is registered with FDA with number: NCT02410694. The sponsor of the trial is Arbeitsgemeinschaft medikamentoese Tumortherapie and it is looking for 77 volunteers for the current phase.
Official trial title:
Ixazomib in Combination With Thalidomide - Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma