Phase 2
Completed N=26
Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma
Source: ClinicalTrials.gov NCT00916058 ↗Enrolled (actual)
26
Serious AEs
17.0%
Results posted
Jun 2019
Primary outcomePrimary: Maximum Tolerated Dose (Phase 1) — 0; 1; 0; 0 Participants
Summary
The purpose of this study is to evaluate the safety and efficacy of Bendamustine (TREANDA™), in combination with Melphalan in subjects with multiple myeloma who are undergoing an Autologous Stem Cell Transplant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (Phase 1) |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Overall Response Rate (Phase 2) - Number of Participants Achieving at Least a Partial Response or Better in Disease Status at Day 100 Post-transplant |
33 | — |
| SECONDARY Progression-Free Survival (Phase 1) |
791 | — |
| SECONDARY Progression-Free Survival (Phase 2) |
47 | — |
| SECONDARY Overall Survival at 2 Years (Phase 1) |
70 | — |
| SECONDARY Overall Survival at 3 Years (Phase 2) |
88 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with multiple myeloma who have received induction therapy and have had stem cells mobilized in preparation for autologous transplantation will be eligible for this study. Patients are also eligible with relapsed or refractory disease, after attempts at more standard approaches, and with the availability of stem cells.
- Patients must be age 18 or older.
- Patients must have a life expectancy of at least 12 weeks.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Patients must provide written informed consent.
Exclusion Criteria
- Impaired renal function with a measured or calculated creatinine clearance of less than 25 ml/min.
- Impaired hepatic function defined as a bilirubin greater than 1.5 x upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 x ULN.
- Serious active or uncontrolled infection or medical condition.
- Women who are pregnant or breast feeding. Women of childbearing age must use adequate contraception and have a negative pregnancy test.
- Impaired pulmonary function with a diffusing capacity of the lung for carbon monoxide (DLCO) less than 45% predicted.
- Impaired cardiac function with an ejection fraction less than 40% of predicted.
- Other systemic anticancer therapy or ongoing toxicities from such therapy.
Data sourced from ClinicalTrials.gov (NCT00916058). 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.