NCT03731832

Pomalidomide, Ixazomib, and Dexamethasone With or Without Intensification by Cyclophosphamide in Relapsed or Refractory Multiple Myeloma

Pomalidomide, Ixazomib, and Dexamethasone (PId) With or Without Intensification by Cyclophosphamide (PICd): A Phase II Study in Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: GWT-TUD GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is designed as a multicenter, non-randomized, Phase II trial with one treatment arm. A total of 82 patients of both genders and older than 18 years with relapsed/refractory multiple myeloma are planned to be included in the study. After the first 6 patients will have finished the first treatment cycle of the induction phase the DMC will assess safety and tolerability of the treatment schedule and decide about the further continuation of the study.

Detailed description

The study is designed as an open-label, non-randomized, multicenter study to investigate the clinical activity of pomalidomide administered once daily in combination with oral ixazomib and dexamethasone (PId) until disease progression according to IMWG criteria. Patients with clinical relapse (any one of the following: deterioration of renal function, hypercalcemia, newly developing osteolytic lesions and/or soft tissue plasmacytomas) will go off study and receive further treatment according to their treating physician. Patients with isolated biochemical relapse with an increase of serum M-protein of ≥ 25% (absolute increase in serum must be ≥ 5 g/L) and/or urine M-protein (absolute increase in urine must be ≥ 200 mg/24h) or in the difference between involved and uninvolved FLC levels (provided, the absolute increase is \> 100 mg/L) without further signs or symptoms will proceed to the intensification phase (PICd). The intensification phase (PICd) will last until further disease progression. In case of significant haematological and non-haematological toxicities, dose adjustments and/or interruption of the study drugs may be necessary. Response assessments will be performed every four weeks by evaluation of serum and 24 hour urine specimens. "Progressive disease" (PD) will require a consecutive confirmatory measurement.

Conditions

• Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	MLN9708	Study drug will be given as a single, oral dose of 4.0 mg weekly (day 1, 8 and 15) for 3 weeks, followed by 1 week without study drug in a 28-day cycle
DRUG	Pomalidomide 4 MG Oral Capsule	Study drug will be given as an oral dose of 4.0 mg on day 1 until day 21, followed by 1 week without study drug in a 28-day cycle.
DRUG	Dexamethasone	Dexamethasone will be administered as a single, oral dose of 40 mg/day weekly on day 1, 8, 15 and 22 in patients from 18 to 74 years old. For patients ≥ 75 years old dose has to be reduced to 20 mg/day with the same treatment schedule.
DRUG	Cyclophosphamide	Cyclophosphamide will be administered once daily as an oral dose of 50 mg on cycle days 1 to 21, followed by one week without drug in a 28-day cycle.

Timeline

• Start date: 2018-09-20
• Primary completion: 2024-04-22
• Completion: 2024-04-22
• First posted: 2018-11-06
• Last updated: 2025-09-30

Locations

11 sites across 1 country: Germany