Clinical trial NCT00334932 (phase 1/phase 2, status: unknown status)
Conditions: multiple myeloma and plasma cell neoplasm
ICD codes: C96.20, C96.29, D47.09
Drugs: bortezomib, melphalan, pegylated liposomal doxorubicin hydrochloride
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
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