human immunoglobulin and one vial of recombinant human hyaluronidase (rHuPH20

Multifocal Motor Neuropathy

human immunoglobulin and one vial of recombinant human hyaluronidase

rHuPH20

UMCU

HyQvia in Multifocal Motor Neuropathy

Subcutaneous Immunoglobulin With rHuPH20 in Multifocal Motor Neuropathy

presence of headache, gastrointestinal complaints, fatigue, flue-like symptoms

VAS questionnaire every visit at the outpatient clinic.

Every visit at the outpatient clinic a Guy's neurologic disability scale (GNDS) and MRC sum score are obtained

QoL questionnaire measured in a VAS number

L.H. van den Berg

Professor dr

UMC Utrecht

Patients will receive single agent carfilzomib on a weekly dosing schedule (days 1, 8, 15) in a 21 day cycle. The initial dose will be 20 mg/m² for cycle 1, day 1. Dose escalation will proceed in a standard 3+3 fashion with the requirement that dose escalation to the next level can only proceed if 0 of 3 or ≤ 1 of 6 patients experience a dose limiting toxicity (DLT). Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses.

Neoplasms

Malignancies

Carfilzomib will be given as an IV infusion over 4 hours. Subjects will remain at the clinic under observation for at least 1 hour following each dose of carfilzomib in Cycle 1 and following the dose on Cycle 2 Day 1. During these observation times, post dose IV hydration may be given at physician's discretion.

Carfilzomib

Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses.

Dexamethasone

Emory University Winship Cancer Institute

Extended Infusion Carfilzomib on a Weekly Schedule in Patients With Advanced Solid Tumors

A Phase I Study of Extended Infusion Carfilzomib on a Weekly Schedule in Patients With Advanced Solid Malignancies

Evaluate safety and tolerability of weekly dosed carfilzomib as assessed by using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4 criteria to determine DLTs, the MTD, and RP2D

Pharmacokinetic analysis (Tmax, Cmax, t1/2, AUC)

Pharmacodynamic (PD) evaluation of degree of 20S proteasomal inhibition in PBMC assays conducted at Emory University before treatment and at time of first restaging scan

Objective Response Rate (CR + PR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients who completed at least 2 cycles of protocol therapy

Clinical Benefit Rate (CR + PR + SD) by RECIST 1.1 criteria in patients who completed at least 2 cycles of protocol therapy

Bradley Carthon MD, PhD

Assistant Professor

Emory University

Amgen

Injection of Mozobil (Plerixafor / AMD3100) in diabetic patients

Injection of Mozobil (Plerixafor / AMD3100) in non diabetic subjects

Diabetes

Subcutaneous injection of 0.24 mg/kg Mozobil once at 8:30am

Mozobil

Policlinico Universitario, Azienda Ospedaliera di Padova

Stem Cell Mobilization With Plerixafor in Diabetic vs Control Subjects

Mobilization Test of BM Progenitor Cells With Plerixafor / AMD3100: Controlled Parallel Group Comparison Between Diabetic and Non Diabetic Subjects

To evaluate the differences of CD34+ cells mobilization from the bone marrow to the peripheral blood induced by a single sc injection of Mozobil in diabetic patients versus non diabetic controls.
Clinical response variable: comparison of the fold change in CD34+ peripheral cell count in diabetic versus non diabetic controls after Mozobil administration (with collection of safety and tolerability data).

to evaluate whether Mozobil monotherapy is able to induce a significant CD34+ stem cells mobilization in diabetic patients (intra-group comparison).
Clinical response variable: detection of a significant fold-change in CD34+ peripheral cell count versus baseline in diabetic patients.

To evaluate the differences in mobilization of EPC (CD34+KDR+) from the bone marrow to the peripheral blood induced by a single sc injection of Mozobil in diabetic patients versus non diabetic controls (inter-group comparison).
Clinical response variable: comparison of the fold change in CD34+ KDR+ peripheral cell count in diabetic versus non diabetic controls after Mozobil administration (with collection of safety and tolerability data).

To evaluate whether Mozobil monotherapy is able to induce a significant EPC mobilization in diabetic patients (intra-group comparison).
Clinical response variable: detection of a significant fold-change in CD34+KDR+ peripheral cell count versus baseline in diabetic patients

multiple myeloma/höfuðverkur

HyQvia in Multifocal Motor Neuropathy

Extended Infusion Carfilzomib on a Weekly Schedule in Patients With Advanced Solid Tumors

Stem Cell Mobilization With Plerixafor in Diabetic vs Control Subjects

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