Clinical trial · Interventional
Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma
Consolidation Therapy With Bortezomib in Patients With Multiple Myeloma Aged 61 to 75
NCT00416208CI-TRIAL-00017012completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the efficacy and safety of a consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bortezomib
- description
- Bortezomib 1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days
- interventionNames
- Drug: Bortezomib
- type
- NO_INTERVENTION
- label
- Observation
- description
- Observational arm
Primary outcomes (1)
- measure
- The difference in event-free survival time will be compared between both arms
- timeFrame
- Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 61 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have had pretreatment with single or tandem high dose melphalan therapy and autologous stem cell transplantation as first line therapy * at least stable disease after stem cell transplantation * adequate hematological, hepatic and renal lab parameters * karnofsky status of 70 or more Exclusion Criteria: * non-secretory multiple myeloma * previous treatment with bortezomib * allogenic stem cell transplantation * other co-existing malignancy beside basaliome * peripheral neuropathy * epilepsia * other severe comorbidities (renal, hepatic, cardiovascular, metabolic, infectious etc.) * history of allergic reactions to bortezomib or mannitol * expected life expectancy of less than 3 months
References
Publications (2)
- DERIVEDStraka C, Knop S, Vogel M, Muller J, Kropff M, Metzner B, Langer C, Sayer H, Jung W, Durk HA, Salwender H, Wandt H, Bassermann F, Gramatzki M, Rosler W, Wolf HH, Brugger W, Fischer T, Liebisch P, Engelhardt M, Einsele H. Bortezomib consolidation following autologous transplant in younger and older patients with newly diagnosed multiple myeloma in two phase III trials. Eur J Haematol. 2019 Sep;103(3):255-267. doi: 10.1111/ejh.13281. Epub 2019 Jul 19. PMID 31231828
- DERIVEDEinsele H, Knop S, Vogel M, Muller J, Kropff M, Metzner B, Langer C, Sayer H, Jung W, Durk HA, Salwender H, Wandt H, Bassermann F, Gramatzki M, Rosler W, Wolf HH, Brugger W, Engelhardt M, Fischer T, Liebisch P, Straka C. Response-adapted consolidation with bortezomib after ASCT improves progression-free survival in newly diagnosed multiple myeloma. Leukemia. 2017 Jun;31(6):1463-1466. doi: 10.1038/leu.2017.83. Epub 2017 Mar 15. No abstract available. PMID 28293022