Clinical trial · Observational
Treatment of Relapsed/Refractory Multiple Myeloma (rrMM) With Pomalidomide in Clinical Practice
Multicenter Non-interventional Study to Investigate Drug Utilization of Pomalidomide in Clinical Practice for the Treatment of Relapsed/Refractory Multiple Myeloma (rrMM)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Pomalidomide and Dexamethasone
- description
- Pomalidomide 4mg capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (\>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity
- interventionNames
- Drug: Pomalidomide
- Drug: Dexamethasone
- label
- Pomalidomide, Bortezomib and Dexamethasone
- description
- Cycle 1-8: Pomalidomide 4mg capsules by mouth (PO) on days 1 through 14 of a 21 day cycle, Bortezomib (1,3mg/m2) s.c. on day 1, 4, 8, 11 of a 21 day cycle, and Dexamethasone 20mg PO (≤75 years) or 10mg (\>75years) on Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21 day cycle until progression or unacceptable toxicity; from cycle 9 onwards: Pomalidomide 4mg capsules by mouth (PO) on days 1 through 14 of a 21 day cycle, Bortezomib (1,3mg/m2) s.c. on day 1 and 8 of a 21 day cycle, and Dexamethasone 20mg PO (≤75 years) or 10mg (\>75years) on Days 1, 2, 8, 9 of a 21 day cycle until progression or unacceptable toxicity
- interventionNames
- Drug: Pomalidomide
- Drug: Dexamethasone
- Drug: Bortezomib
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available