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:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT00334932
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of multiple myeloma
* Stage I, II, or III disease according to Durie-Salmon staging criteria
* Progressive disease, defined as one of the following:
* For secretory disease:
* A 25% increase in serum M-protein or Bence Jones protein (an absolute increase of 0.5 g/dL serum M-protein or ≥ 200 mg/24 hours of urine light chain excretion)
* For nonsecretory disease:
* Bone marrow biopsy with \> 25% increase in plasma cells or an absolute increase of ≥ 10% over prior known level
* Development of new or worsening existing lytic bone lesions or soft tissue plasmacytomas
* Hypercalcemia (i.e., calcium \> 11.5 mg/dL)
* Relapsed after complete response
* Must have received ≥ 2 of the following therapeutic regimens for multiple myeloma:
* Nonmyeloablative transplantation
* No significant graft-versus-host disease
* At least 30 days since prior immunosuppressive therapy (concurrent prednisone allowed provided dose is ≤ 10 mg daily)
* Mobilization with chemotherapy followed by either single or tandem autologous stem cell transplantation (considered 1 prior regimen)
* Mobilization with chemotherapy followed by autologous and subsequent nonmyeloablative allogeneic stem cell transplantation (considered 1 prior regimen)
* Any combination of drugs given concurrently (considered 1 prior regimen)
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 3 months
* Absolute neutrophil count \> 1,000/mm\^3 (no colony-stimulating factors)
* Platelet count \> 50,000/mm\^3 (no transfusion support)
* Bilirubin ≤ 2.0 mg/dL
* AST ≤ 4 times upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
* No history of allergic reaction to compounds containing boron or mannitol
* No active uncontrolled viral (including HIV), bacterial, or fungal infection
* No motor or sensory neuropathy ≥ grade 2
* No myocardial infarction within the past 6 months
* No New York Heart Association class III or IV heart failure
* No uncontrolled angina
* No severe uncontrolled arrhythmia
* No acute ischemia by EKG
* LVEF ≥ 35% by MUGA (MUGA required in patients whose lifetime cumulative doxorubicin hydrochloride dose \> 400 mg/m\^2)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No grade III or IV toxicity due to previous antineoplastic therapy (except alopecia)
* At least 3 weeks since prior chemotherapy
* No prior doxorubicin HCl liposome, melphalan, and bortezomib as combination therapy (single or two-drug combinations of these are allowed)
* No concurrent corticosteroids (≤ 10 mg prednisone/day or equivalent allowed)
* No other concurrent chemotherapy
* No concurrent thalidomide
* No other concurrent investigational therapy
* No other concurrent antineoplastic treatment for multiple myeloma, including clarithromycin
* No concurrent radiation therapy
* No concurrent nonsteroidal anti-inflammatory agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00334932
Study Brief:
Protocol Section:
NCT00334932