Phase 2
Completed N=32
Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma
Source: ClinicalTrials.gov NCT00581919 ↗Enrolled (actual)
32
Serious AEs
31.3%
Results posted
Aug 2016
Primary outcomePrimary: Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR — 53 percentage of participants
Summary
Patients will receive Bortezomib, Dexamethasone, and Doxorubicin in 21 day cycles a total of 4 to 8 times (based on response to the treatment). Patients will also receive acetyl-L-carnitine (ALCAR) daily.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR |
53 | — |
| SECONDARY Overall Survival |
28.3 | — |
| SECONDARY Progression-free Survival |
5 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with previously treated multiple myeloma with measurable serum or urine monoclonal protein.
Exclusion Criteria
- Patients with previous doxorubicin treatment totaling 220 mg/m2 or more
- LVEF less than 45%
- Patients with >grade II sensory neuropathy at baseline as assessed by the PI will be excluded
- No history of seizures as ALCAR may lower the seizure threshold
- Known HIV infection
- Current pregnancy.
Data sourced from ClinicalTrials.gov (NCT00581919). 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.