Clinical trial · Interventional
Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma
A Phase I/II Trial of Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed or Refractory Multiple Myeloma: Hoosier Cancer Research Network MM08-141
NCT01177683CI-TRIAL-00070284terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of accrual
Summary
Brief summary (as posted)
This is an open label phase I/II trial to determine the safety and the biologic activity of the bendamustine, bortezomib and pegylated liposomal doxorubicin combination.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Bortezomib | Drug | Bortezomib | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Filgrastim | Drug | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Bendamustine in combination with bortezomib and pegylated liposomal doxorubicin.
- interventionNames
- Drug: Bendamustine
- Drug: Doxorubicin
- Drug: Bortezomib
- Drug: Filgrastim
Primary outcomes (2)
- measure
- Phase I: MTD of Bendamustine When Combined With Bortezomib and Pegylated Liposomal Doxorubicin.
- timeFrame
- From C1D1 up to a maximum of 7 months or until death
- description
- In the first phase, MTD of bendamustine was determined in combination with bortezomib and pegylated liposomal doxorubicin to gain a better idea of safe dosing before proceeding with the second phase to assess efficacy. Assuming myelosuppression being a dose-limiting effect that could have been overcome with growth factor support, MTD of the combination with myeloid growth factor support was also tested.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A histologically established diagnosis of multiple myeloma with evidence of relapse or refractory disease. * Must have a detectable serum or urine M-Protein by protein electrophoresis that is at least 500 mg/dL (serum) or 1 gm/24 hours (urine), respectively, or serum free light chain level \>100 mg/l for the involved free light chain. * Must have received at least one (1) prior line of systemic treatment that has included either lenalidomide or thalidomide. * Must be willing to provide correlative blood samples. Exclusion Criteria: * Must not have received an excessive cumulative dose of anthracycline * No ≥ grade 2 peripheral neuropathy. * No cytotoxic chemotherapy within 30 days prior to registration for protocol therapy. * No autologous stem cell transplant within 6 months prior to registration for protocol therapy * No prior radiation therapy to \> 25% of bone marrow forming bones (i.e., pelvis) within 30 days prior to registration for protocol therapy. See Study Procedures Manual to calculate percent of prior radiation. * No current corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions. * No known central nervous system involvement by myeloma. * No poorly controlled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled diabetes, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social climate that in the opinion of the investigator would limit compliance with study requirements. * No patients known to be positive for HIV, or active Hepatitis A, B, or C. * No major surgery within 30 days prior to registration for protocol therapy. Placement of a venous access device within 30 days prior to registration for protocol therapy is allowed.
References
Publications (0)
Data not yet available
No reference posted for this study.