Phase 2
Completed N=46
Bortezomib, Doxorubicin Hydrochloride Liposome, and Thalidomide as First-line Therapy in Treating Patients With Previously Untreated Stage I, II, or III Multiple Myeloma
Source: ClinicalTrials.gov NCT00523848 ↗Enrolled (actual)
46
Serious AEs
36.4%
Results posted
Sep 2013
Primary outcomePrimary: Overall Response Rate (Complete and Partial) — 77.50 percentage of participants
Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving bortezomib together with doxorubicin hydrochloride liposome and thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin hydrochloride liposome and thalidomide works as first-line therapy in treating patients with previously untreated multiple myeloma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (Complete and Partial) |
77.50 | — |
| SECONDARY Complete Response Rate |
22.50 | — |
| SECONDARY Time to Disease Progression |
27.8 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of stage I, II, or III multiple myeloma requiring therapy
- No prior systemic therapy for multiple myeloma
- Patients who have received steroids or radiotherapy for cord compression or spinal cord disease are eligible for this study
- Patients who have received 1 prior course of antimyeloma therapy may be enrolled at the investigator's discretion provided disease progression is not noted
PATIENT CHARACTERISTICS:
Inclusion criteria
- Karnofsky performance status 60-100%
- Platelet count ≥ 75, 000 cells/mm^3 ( 20 mL/min
- AST and ALT ≤ 2 times upper limit of normal (ULN) OR ≤ 3 times ULN (in the presence of liver metastases)
- Alkaline phosphatase ≤ 2 times ULN OR ≤ 3 times ULN (in the presence of liver metastases)
- Total bilirubin ≤ 2 times ULN OR ≤ 3 times ULN (in the presence of liver metastases)
- Ejection fraction ≥ 50% by MUGA or 2-D echocardiogram
- Negative pregnancy test
- Fertile patients must use at least 1 highly effective and 1 additional effective contraception method 4 weeks prior to, during, and 3 months after completion of study therapy
- HIV-negative
- Must have sufficient mental capacity to understand the explanation of the study and to provide informed consent
- Willingness and ability to comply with the FDA-mandated S.T.E.P.S. program
Exclusion criteria
- Pregnant or lactating
- Active, serious infections uncontrolled by antibiotics
- Any medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in this clinical trial
- History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or the components of doxorubicin hydrochloride liposome or bortezomib, boron, or mannitol
- Any of the following conditions:
- History of uncontrolled New York Heart Association class II-IV heart disease or clinical evidence of congestive heart failure
- Myocardial infarction within the past 6 months
- Uncontrolled angina
- Severe uncontrolled ventricular arrhythmias, ECG evidence of acute ischemia, or active conduction system abnormalities
- Peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Data sourced from ClinicalTrials.gov (NCT00523848). 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.