Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT00458705
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically and serologically confirmed multiple myeloma meeting one of the following criteria:
* High-risk myeloma, defined as symptomatic International Staging System (ISS) stage 2 or 3 multiple myeloma
* Soft-tissue involvement with myeloma in the form of a soft-tissue plasmacytoma
* Extension of a plasmacytoma into soft tissues
* Primary resistant myeloma, defined as unchanged or progressive myeloma despite two courses of standard treatment
* No ISS stage 1 multiple myeloma without soft-tissue involvement
* No smoldering myeloma
PATIENT CHARACTERISTICS:
* ECOG performance status 0-3
* Life expectancy \> 16 weeks
* Absolute granulocyte count ≥ 1,500/mm³ (unless low granulocyte counts are due to multiple myeloma)
* Platelet count ≥ 100,000/mm³ (unless low platelet counts are due to multiple myeloma)
* Bilirubin ≤ 2.0 mg/dL
* AST and ALT \< 3 times upper limit of normal (ULN)
* Alkaline phosphatase \< 3 times ULN
* LVEF ≥ 50% by MUGA or ECHO
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception 4 months prior to, during, and for 4 weeks after completion of study treatment
* No active thromboembolic disease on anticoagulation
* No active angina or myocardial infarction within the past 6 months
* No pre-existing neuropathy or sensory or neuropathic pain ≥ grade 2
* No concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
* Prior malignancies that have not required antitumor treatment within the past 24 months allowed
* Patients with a history of stage I or II (T1a/b) prostate cancer (detected incidentally at transurethral resection of prostate \[TURP\] and comprising \< 5% of resected tissue) allowed if the prostate-specific antigen has remained normal since TURP
* No known HIV positivity or AIDS-related illness
* No other medical condition or reason that, in the opinion of the investigator, would preclude study compliance
* No history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or to components of pegylated doxorubicin hydrochloride liposome, bortezomib, boron, or mannitol
PRIOR CONCURRENT THERAPY:
* Prior radiotherapy allowed
* No more than 2 courses of prior initial chemotherapy for multiple myeloma
* No prior bortezomib
* No prior high-dose steroids (not including taper) for more than 1 month in duration for emergent indications, such as hypercalcemia or life-threatening lesions (e.g., spinal cord compromise) (in high-risk patients)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00458705
Study Brief:
Protocol Section:
NCT00458705