Clinical trial · Interventional
Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Phase II Study of Bendamustine, Bortezomib, and Dexamethasone (BBD) for Newly Diagnosed Patients With Multiple Myeloma
- 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)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage II Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage I Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine hydrochloride | Drug | Bendamustine | ALIAS |
| Bortezomib | Drug | Bortezomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bendamustine, Bortezomib, Dexamethasone (Standard)
- description
- Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.
- interventionNames
- Drug: Bendamustine hydrochloride
- Drug: Bortezomib
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd
- timeFrame
- At least 140 days
- description
- ORR (partial remission or better) to induction therapy following 4 cycles of the combination regimen BBd.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. New diagnosis of multiple myeloma with no prior history of systemic treatment (Exceptions include corticosteroids, bisphosphonates, single agent cyclophosphamide, \<= 21 days of the first cycle of a planned regimen 2. \>= 18 years of age 3. ECOG \<= 3 4. Signed informed consent 5. Measurable serum paraprotein on SPEP or serum free light chains and ratio, or quantifiable Bence-Jones proteinuria on 24 hour urine specimen. If the monoclonal protein has merged with the beta region we will follow the serum immunoglobulin of the involved heavy chain and comment on either partial remission (PR, as judged by two protocol investigators) or complete remission (CR, as defined by the achievement of PR as above and the resolution of the monoclonal protein by immunofixation in the serum and urine.) Exclusion Criteria: 1. Failure to sign informed consent 2. Smoldering myeloma, monoclonal gammopathy of undetermined significance (MGUS), or plasma cell leukemia 3. History of previously treated smoldering myeloma 4. Grade 3 or above peripheral neuropathy 5. Uncontrolled human immunodeficiency virus (HIV) 6. Active hepatitis A, B or C 7. Pregnant or lactating females 8. Total bilirubin \>3 times the upper limit of normal 9. ASLT/ALT \> 2.5 times the upper limit of normal
References
Publications (0)
Data not yet available