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A Phase II study of Selinexor (KPT-330) combined with bortezomib and dexamethasone (SVd) for induction and consolidation for patients with progressive or refractory Multiple Myeloma.

Part I: Evaluate the safety and tolerability of selinexor at 3 different dose levels in combination with bortezomib/dexamethasone & determine recommended dose level (RDL) of selinexor for Part IIPart II: Evaluate the efficacy of the…

A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and
Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care
Compared With Best Supportive Care in Subjects With Multicentric Castleman*s
Disease

Primary Objective:The primary objective of this study is to demonstrate that CNTO 328 in combination with BSC is superiorto BSC in terms of objective response (complete response [CR] + partial response [PR]) among subjectswith multicentric Castleman…

A Phase 3, Randomized, Double-blind Study of Siltuximab (Anti-IL-6 Monoclonal Antibody) or Placebo in Combination With VELCADE and Dexamethasone for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma

The primary objective of this study is to determine if there is an improvement in progression-free survival(PFS) when siltuximab is added to VELCADE* (bortezomib) and dexamethasone in subjects with relapsedor refractory multiple myeloma.The…

A phase II study of Vorinostat in patients with Polycythaemia Vera and Essential Thrombocythaemia

1. To evaluate efficacy of vorinostat in the treatment of patients with polycythaemia vera (PV) and essential thrombocythaemia (ET) 2. To evaluate if vorinostat as monotherapy of patients with PV and ET is followed by a decline in clonal…

Intra-marrow transplantation of Mesenchymal Stromal Cells to treat MyeloDysplastic Syndromes: A feasibility study

This proposed study has three main objectives:1. To determine the feasibility of intra-marrow transplantation (IMT) of MSCs in lower risk MDS patients (a Phase I/II study):Although we have experience with application of (unrelated) MSCs and intra-…

A Phase Ib/II, open-label, multi-center, dose-finding study to assess the safety and efficacy of the oral combination of LDE225 and INC424 (Ruxolitinib) in patients with myelofibrosis

To establish the MTD and/or recommended phase II dose of the coadministration of LDE225 and INC424 in patients with MF, who have not previously received therapy with a JAK inhibitor

Generation of Dendritic cells from patients with breast cancer, multiple myeloma or ovarian cancer

To study (in vitro) if dendritic cells can be cultured with cells obtained from peripheral blood of patients with either m. myeloma, ovarian cancer or breast cancer. Thusfar we worked with cells from healthy volunteers. Before performing clinical…

The predictive value of 18F-FDG-PET to demonstrate disease activity in patients with relapsed multiple myeloma; a pilot study

To demonstrate the accuracy of FDG-PET for defining disease activity in relapsed MM patients in comparison to X-ray and somatostatin receptor scintigraph (SRS).

An Open-label, Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma

The primary objective is to compare the overall response rate ORR(CR+PR), after 4 cycles, of subcutaneously (SC) administered VELCADE tointravenously (IV) administered VELCADE in patients with previouslytreated multiple myeloma.The secondary…

Open-Label, Multi-Center, Phase 2 Study of Anti-CCR4 Monoclonal Antibody KW 0761 (mogamulizumab) in Subjects with Previously Treated Peripheral T-cell Lymphoma (PTCL)

The primary objective of this study will be:* To determine the overall response rate of KW-0761 for the treatment of patients with relapsed or refractoryPTCL;The secondary objectives of this study will be:* To determine the duration of response,…

A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase 2 Study of LY2127399 in Combination with Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma

The primary objective is to compare PFS after treatment with tabalumab, bortezomib, anddexamethasone to that of placebo, bortezomib, and dexamethasone in patients with relapsed/refractory MM.Secondary objectives will include comparison of treatment…

Phase II single arm open pilot study to demonstrate the efficacy of midostaurin in symptom improvement and decrease of mast cell burden in patients with indolent or smoldering systemic mastocytosis

Primary: To study the efficacy and tolerability of Midostaurin in patients with indolent or smoldering systemic mastocytosis on mediator symptom reduction.Secondary: 1) To study whether Midostaurin can reduce mast cell infiltration and 2) to assess…

A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

The primary objective is to compare the efficacy of two dose-schedule arms(s) of pacritinib (pooled once daily [QD] and twice-daily [BID] dosing arms) with that of best available therapy (BAT) in patients with thrombocytopenia and primary…

A Phase II multi-center, open label, randomized study to assess safety and efficacy of two different schedules of oral LDE225 in adult patients with relapsed/refractory or untreated elderly patients with acute leukemia

During the last several years, substantial progress has been made regarding the biologic characterization of the acute leukemias. The traditional understanding that myeloid leukemic cells are developmentally similar to their normal hematopoietic…

Use of combined FDG-PET/CT in diagnosing infectious complications in patients treated with intensive chemotherapy and stem cell transplant recipients for haematological malignancy.

The expectation is that FDG-PET demonstrates or excludes infectious complications earlier than current practice, resulting in more efficient use of other diagnostic methods and therapy. Besides early detection and treatment of invasive fungal…

An open label extension study to evaluate the safety of long term dosing of AMG 531 in trombocytopenic subjects with myelodysplastic syndromes (MDS).

To provide long-term safety data for the use of AMG 531 in thrombocytopenic subjects with IPSS low or intermediate-1 risk MDS.

A phase I clinical trial to study the safety of treatment with Tipifarnib (ZARNESTRA) combined with Bortezomib (VELCADE) in patients with myelodysplastic syndrome (MDS)

To assess the safety of treatment with escalating dosages of VELCADE in combination with ZARNESTRA in subjects with Intermediate-2 or high risk MDS according to the IPSS classification.

Somatostatin receptor scintigraphy in patients with multiple myeloma or plasmocytoma

Objective of the studyThe present pilot study will be focused to define the sensitivity of SRS in MM patients and in patients with plasmacytoma. This in comparison to X-ray examination. In addition it will be investigated whether SRS can be used as…

Are intrinsic defects of the stem cell compartment responsible for the peripheral pancytopenia post-transplantation.

- To determine the numbers of dividing cells focused whether hyperproliferation or hypoplasia can be determined.- To determine whether the progenotor or stem cell is different affected.- Can intrinsic defects of the CD34+ cells be demonstrated that…

An Open Label, Sequential Cohort, Dose Escalation Study to Evaluate the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

To evaluate safety and tolerability of AMG 531 in patients with low or intermediary-1 risk MDS and thrombocytopenia and to evaluate thrombocyte response at AMG 531 in these patients.