Treatment of Relapsed/Refractory Multiple Myeloma (rrMM) With Pomalidomide in Clinical Practice

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

There is a high unmet medical need for an anti-myeloma therapy for RRMM patients previously treated with Lenalidomide and Bortezomib, due to poor prognosis.

This observational study focuses on the collection of data concerning the safe and optimal usage of Pomalidomide, a new therapy option for RRMM patients, thereby increasing the knowledge about optimal AE management. Beside this, further analysis of tolerability, dosage and efficacy will be performed.

This knowledge could lead to a optimization of Pomalidomide usage and treatment.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Pomalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Signed IC

• age ≥ 18 years

• relapsed/refractory MM

• cohort A (combination pomalidomide und dexamethasone):

≥2 antimyeloma treatments (including lenalidomide and bortezomib), induction therapy followed by ASCT and consolidation or maintenance therapy is considered as 1 antimyeloma treatment

• cohort B (combination pomalidomide, bortezomib and dexamethasone):

≥1 antimyeloma treatments (including lenalidomide) induction therapy followed by ASCT and consolidation or maintenance therapy is considered as 1 antimyeloma treatment

• refractory to last antimyeloma treatment

• adequate contraception according to RMP

• adequate thrombosis prophylaxis

Exclusion Criteria:

1. Pregnant or Lactating Females

2. Known hypersensitivity to Imnovid