Clinical trial NCT01220375 (phase 2, status: completed)
Conditions: myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: vinorelbine, g-csf, & plerixafor, vinorelbine and plerixafor, g-csf and plerixafor, vinorelbine & plerixafor on day when cd34 count is at least 15'000 cd34+ cells/ml of peripheral blood
SMILES: C(N1CCCNCCNCCCNCC1)C1=CC=C(CN2CCCNCCNCCCNCC2)C=C1, [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, C(N1CCCNCCNCCCNCC1)C1=CC=C(CN2CCCNCCNCCCNCC2)C=C1, [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
Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic stage I or stage II and III myeloma patients after standard first-line
             non-melphalan containing induction treatment. Patients must be fit for subsequent
             consolidation with high-dose chemotherapy with melphalan with autologous stem cell
             support.

          -  Standard induction chemotherapy comprises regimens including thalidomide, bortezomib,
             or lenalidomide (up to 4 cycles), alone or in combination with dexamethasone.
             Combinations of novel agents are allowed as well as induction with the VAD regimen.

          -  Patients must have achieved at least a partial response according to the Bladé
             criteria after induction chemotherapy.

          -  Patient must be aged 18-70 years, with an ECOG < 2 and has given voluntary written
             informed consent.

          -  Platelets count 50 x 109/l without transfusion support within 7 days before the
             laboratory test.

          -  Absolute neutrophil count (ANC) 1.0 x 109/l without the use of colony stimulating
             factors.

          -  Corrected serum calcium < 3 mmol/L.

          -  Aspartate transaminase (AST) <= 1.5 x ULN.

          -  Alanine transaminase (ALT) <= 1.5 x ULN.

          -  Total bilirubin <= 2 x ULN.

          -  Creatinin-clearance >= 50 ml/min.

          -  Negative pregnancy test within 14 days prior to registration for all women of
             childbearing potential. Patients of childbearing potential must implement adequate
             measures to avoid pregnancy during study treatment and for additional 12 months. No
             pregnant or lactating patients are allowed.

        Exclusion Criteria

          -  Patients previously treated with melphalan or extensive radiotherapy to the bone
             marrow.

          -  Patients with more than 4 cycles of chemotherapy with Lenalidomide.

          -  Patients not fit for autologous stem cell transplantation.

          -  Patient receiving colony stimulating factors.

          -  Patient underwent plasmaphereses within 4 weeks before enrolment.

          -  Patient had major surgery within 4 weeks before enrolment.

          -  Patient has other serious medical condition that could potentially interfere with the
             completion of treatment according to this protocol or that would impair tolerance to
             therapy or prolong hematological recovery.

          -  Sero-positive for HIV antibody.

          -  Patient known to be hepatitis B surface antigen positive or who has an active
             hepatitis C infection.

          -  Patient has an active systemic infection requiring treatment.

          -  Female patient is pregnant or breast feeding.

          -  Compromised renal function as evidenced by measured or calculated creatinine clearance
             <= 50 ml/min.

          -  Subject is currently enrolled in, or has not yet completed at least 30 days since
             ending another investigational device or drug trial or is receiving other
             investigational agent.