Neoplasms

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Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

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Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

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Anti-Inflammatory Agents

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All Drugs and Chemicals

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Anti-Infective Agents

Dexamethasone

Cyclophosphamide

Pomalidomide

Dexamethasone acetate

Ixazomib

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Alkylating Agents

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Treatment of eligible patients with combination of Pomalidomide, Ixazomib, Dexamethasone for all patients until disease progression.

Treatment of patients showing an isolated biochemical relapse at disease progression with combination of Pomalidomide, Ixazomib, Dexamethasone plus Cyclophosphamide.

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

MLN9708

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.

Pomalidomide 4 MG Oral Capsule

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.

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.

Stefan Knop, Prof.

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.

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.

All patients receive PId. Patients showing a biochemical relapse receive PICd afterwards, while patients showing a clinical relapse go off study.

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

Evaluation of molecular cytogenetic abnormalities

Incidence, severity and relationship of AEs/SAEs of the dosing regimens (safety measures)

Disease control rate in patients receiving PId (at least SD)

Overall response rate (PR or better) for patients intensified with PICd

Disease control rate in patients intensified with PICd (at least SD)

Progression-free survival (PFS) for patients receiving PId and for patients receiving PICd

Spots Global Cancer Trial Database for pomalidomide 4 mg oral capsule