Clinical trial · Interventional
A Study of Bortezomib as Consolidation Therapy in Patients With Multiple Myeloma
Consolidation Therapy With Bortezomib <= 60 Year Old Patients With Multiple Myeloma
NCT00416273CI-TRIAL-00017051completedPhase 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 determination of the event-free survival with and without Bortezomib consolidation therapy from the day of the first chemotherapeutic, myeloma-specific therapy measure, up to the occurrence of progression/recurrence or up to the occurrence of death.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| No intervention | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- Participants in the treatment group will receive Bortezomib at a dosage of 1.6 mg/m2.
- interventionNames
- Drug: Bortezomib
- type
- EXPERIMENTAL
- label
- Observation group
- description
- Participants in the observation group will not receive any consolidation therapy.
- interventionNames
- Drug: No intervention
Primary outcomes (1)
- measure
- Number of patients with event-free survival (PFS)
- timeFrame
- From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with multiple myeloma with prior therapy consisting of remission induction therapy and high dose chemotherapy followed by stem cell transplantation * Women must be postmenopausal or using safe contraception methods * Creatinin clearance has to be higher than 30 ml/min and whole blood count has to be within acceptable ranges Exclusion Criteria: * No asecretory multiple myeloma * History of allergic reactions to bortezomib or mannitol * Expected life expectancy of less than 3 months * No other malignant disease beside basalioma either existing or history of * No history of severe cardio-pulmonary disease * Seizures
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