Clinical trial · Interventional
Bortezomib and High-dose Melphalan at Myeloma Relapse
Phase II Study of Bortezomib Dexamethasone and High-dose Melphalan in Patients With Relapse After High-dose Melphalan With Autologous Stem Cell Support
- 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 prognosis after retreating with high-dose melphalan with stem cell support after first relapse after high-dose treatment is dependent on the time to first relapse. Bortezomib can increase chemosensitivity of e.g. melphalan. The trial aims at determining the toxicity of adding bortezomib to high-dose melphalan with stem cell support and evaluating whether the time to a second relapse can be prolonged.
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 (0)
[]Primary outcomes (1)
- measure
- Comparison of the event free survival after first high-dose melphalan with stem cell support (ASCT) and a second ASCT combined with bortezomib treatment of first relapse
- timeFrame
- 3 years
Secondary outcomes (4)
- measure
- Determining the toxicity of bortezomib as part of the high-dose melphalan conditioning
- timeFrame
- 3 years
- measure
- Response rate of the second ASCT
- timeFrame
- 3 years
- measure
- Marrow regeneration
- timeFrame
- 3 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * First relapse after ASCT * Symptomatic myeloma * More than 2,0 x 10\^6 CD34+ stem cells / kg bodyweight in the freezer for stem cell support * Signed informed consent given prior to any study related activities have been performed * Age \> 18 years Exclusion Criteria: * Allogeneic transplantation scheduled as a part of the treatment * Expected survival of less than one month. * Performance status (WHO) \> 3 * Neuropathy \> Grade 3 (neurological symptoms interfering with ADL) * Non-secreting myeloma * Other concurrent disease making bortezomib treatment unsuitable * Positive pregnancy test (only applicable for women with childbearing potential) * Has known or suspected hypersensitivity or intolerance to melphalan, dexamethasone, boron, mannitol, or heparin, if an indwelling catheter is used * Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 6, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis * History of hypotension or has decreased blood pressure (sitting systolic blood pressure \[SBP\] \<= 100 mmHg and/or sitting diastolic blood pressure \[DBP\] \<= 60 mmHg) * Serious medical or psychiatric illness likely to interfere with participation in this clinical study * Have received an experimental drug or used an experimental medical device within 4 weeks prior to inclusion into the study
References
Publications (0)
Data not yet available