Clinical trial NCT01055301 (phase 2, status: withdrawn)
Conditions: multiple myeloma, plasma cell myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: bortezomib, cisplatin, cyclophosphamide, dexamethasone, doxorubicin hydrochloride, etoposide, lenalidomide, melphalan, thalidomide
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, ClCCN(CCCl)P1(=O)NCCCO1, C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, 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, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O, N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O, CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2
Reason stopped: 
    lack of accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Newly diagnosed active multiple myeloma (MM)

          -  Measurable disease

               -  Non-secretory disease allowed provided patient has ≥ 20% plasmacytosis or
                  multiple (> 3) focal plasmacytomas on skeletal survey and/or MRI

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status (PS) 0-2 (Zubrod PS 3-4 allowed if based solely on bone
             pain)

          -  ANC ≥ 1,500/mm^3*

          -  Platelet count ≥ 150,000/mm^3*

          -  Serum creatinine clearance of ≥ 60 mL/min

               -  Patients with creatinine clearance of < 60 mL/min receive a lower dose of
                  melphalan

               -  No patients receiving or planning to receive dialysis

          -  Total bilirubin ≤ 1.5 times upper limit of normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

               -  Must be fully aware of the teratogenic potential of thalidomide

               -  Must be willing to comply with the FDA-mandated S.T.E.P.S. program

          -  Ejection fraction > 40% as measured by MUGA scan or two-dimensional ECHO

          -  No peripheral neuropathy ≥ grade 2 per CTCAE v. 4.0

          -  No known hypersensitivity to bortezomib, boron, or mannitol

          -  No uncontrolled diabetes defined as fasting glucose level > 200 mg/dL on at least more
             than two occasions or more that two serum random blood levels > 300 mg/dL despite
             adequate treatment

               -  Patients with a history of diabetes mellitus requiring treatment should be on a
                  stable regimen and have their blood glucose closely monitored

          -  No other malignancy within the past 5 years except for adequately treated basal cell
             or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the
             patient has not received treatment within the past year NOTE: *Unless myeloma-related
             marrow infiltration is documented, defined as ≥ 30% marrow cellularity with 50% of the
             cells being malignant plasma cells.

        PRIOR CONCURRENT THERAPY:

          -  At least 4 weeks since prior chemotherapy or radiotherapy

          -  No more than 1 prior course of chemotherapy for MM

               -  Prior chemotherapy must not have included melphalan

          -  No prior radiotherapy to large area of the pelvis (more than half of the pelvis)

          -  Prior radiotherapy for symptomatic localized bone lesions or impending cord
             compression allowed