Phase 2
Completed N=24
Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Source: ClinicalTrials.gov NCT02224729 ↗Enrolled (actual)
24
Serious AEs
37.5%
Results posted
Jun 2018
Primary outcomePrimary: Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd — 13 Participants
Summary
This phase II trial studies side effects and how well bendamustine hydrochloride, bortezomib, and dexamethasone work in treating patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bendamustine hydrochloride with bortezomib and dexamethasone may kill more cancer cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd |
13 | — |
| SECONDARY Incidence of Grade 3-4 Adverse Events From the Combination of Bendamustine Hydrochloride, Bortezomib, and Dexamethasone Based on the Common Terminology Criteria Version 4.0 |
22 | — |
| SECONDARY Count of Participants That Experience Very Good Partial Remission (VGPR) |
9 | — |
| SECONDARY Count of Participants That Experience Progression-free Survival (PFS) |
2 | — |
| SECONDARY Count of Participants That Experience Overall Survival (OS) |
2 | — |
Eligibility Criteria
Inclusion Criteria
- New diagnosis of multiple myeloma with no prior history of systemic treatment (Exceptions include corticosteroids, bisphosphonates, single agent cyclophosphamide, = 18 years of age
- ECOG 3 times the upper limit of normal
- ASLT/ALT > 2.5 times the upper limit of normal
Data sourced from ClinicalTrials.gov (NCT02224729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.