Alternate Day Dosing of Pomalidomide in Patients With Refractory Multiple Myeloma

• Status: Terminated
• Trial end date: 2021-02-03
• Target enrollment: 0
• Participant gender: All

Summary

Pomalidomide is an approved treatment for refractory multiple myeloma. Toxicity of pomalidomide in the pivotal MM-003 trial, was considerable, with 60% of patients experiencing drug-related G3/4 toxicity. Neutropenia (48% vs 16%) and pneumonia (13% vs 8%) were significantly more common in the pomalidomide arm. This resulted in frequent dose interruptions (67%) and dose reductions (27%). This suggests that for the majority of patients the 4 mg daily dosing schedule is too toxic, and that strategies to deliver reduced dosing of pomalidomide are of high practical relevance. The aim of this trial therefore is to establish that alternate day dosing of pomalidomide (4 mg q2d, d1-28) is non-inferior to daily dosing (4 mg d1-21 q28) in terms of efficacy of the drug with potentially less side effects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Pomalidomide; Thalidomide

Criteria

Key inclusion criteria:

• Patient was diagnosed with multiple myeloma based on standard IMWG criteria

• Prior treatment with ≥ 2 treatment lines of anti-myeloma therapy

• Patients must have been exposed to both lenalidomide and bortezomib

• Measurable disease for myeloma defined as one of the following: serum M-protein ≥ 5 g/L; urine M-protein ≥ 0.2 g/24 hours

• Refractory or relapsed and refractory disease defined as documented disease progression during or within 60 days of completing their last myeloma therapy.

• Adequate hematological and hepatic function

• A negative pregnancy test before inclusion into the trial is required for all women with child-bearing potential

Key exclusion criteria:

• History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration, with the exception of pT1-2 prostate cancer Gleason score ≤6, adequately treated, cervical carcinoma in situ or localized non-melanoma skin cancer.

• Polyneuropathy grade > 2

• Patients who received any of the following within the last 14 days of initiation of trial treatment:

• Plasmapheresis

• Major surgery (kyphoplasty is not considered major surgery)

• Radiation therapy

• Use of any anti-myeloma drug therapy

• Known or clinically suspected myeloma manifestations in the central nervous system

• Severe or uncontrolled cardiovascular disease