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Studien: AGMT_MM2 |  AGMT_MM-1/ EMN-13 |  HO95/EMN02 | 

 


AGMT_MM2

Coordinating Investigator: Prof. Dr. Heinz Ludwig
Fallzahl: 140
Start: Q3 2016 | Ende: Q3 2023
Status: recruiting


A randomized Phase II, 2-armed study in transplant ineligible patients with newly diagnosed multiple myeloma (NDMM) comparing Carfilzomib + Thalidomide + dexamethasone (KTd) versus Carfilzomib + Lenalidomide + dexamethasone (KRd) induction therapy with respect to response rates and investigating a Carfilzomib (K) monotherapy maintenance strategy

Studiendesign

This is a randomized, 2-arm phase II, multi-center study to evaluate overall response rates in newly diagnosed, transplant ineligible patients receiving 9 cycles induction therapy with either KTd or KRd followed by randomization to either Carfilzomib
maintenance treatment or observation only.
The patient population will consist of adult male and female patients with newly diagnosed multiple myeloma (MM), who are not eligible for or not willing to undergo autologous stem cell transplantation.
Treatment will be discontinued in case of progressive disease, in case of no response after 4 cycles, or due to intolerance.
A safety analysis will be conducted after 10 patients completed at least two cycles of KRd or KTd.

Studienziele

Primary objective: To show non-inferiority with respect to response rates between KTd and KRd: to determine ORR in patients after receiving 9 cycles induction therapy with either carfilzomib in combination with thalidomide and dexamethasone or carfilzomib in combination with lenalidomide and dexamethasone

Secondary objectives:
• Feasibility, safety and efficady of a K monotherapy maintenance
• PR, VGPR, CR, sCR, MDR according to IMWG
• PFS of induction arm with or without maintenance
• OS of patients reveiving either KTd vs. KRd induction therapy
• Quality of Life
• Safety and tolerability of KTd and KRd

Einschlusskriterien (Auszug)

• Male or female patients ≥ 18 years
• Newly diagnosed multiple myeloma (MM), who are not eligible for or not willing to undergo autologous stem cell transplantation.
• Measurable disease, as defined by one or more of the following (assessed within 21 days prior to randomization):
- Serum M-protein ≥0.5 g/dL, or
- Urine M-protein ≥200 mg/24 hours, or
- In subjects without detectable serum or urine M-protein, serum-free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal ĸ/λ ratio
• No prior treatment for multiple myeloma
• ECOG performance status of 0, 1 or 2
• Adequate organ and bone marrow function:
- Bilirubin <1.5 times the upper limit of normal (ULN)
- AST and ALT < 3 times the ULN
- Absolute neurtophil count (ANC) ≥ 1000/mm3
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 50.000/mm3

Öffentliche Downloads

AGMT_MM2 Poster
Poster am OeGHO 2017



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AGMT_MM-1/ EMN-13

Coordinating Investigator: Prof. Dr. Heinz Ludwig
Fallzahl: 77
Start: 09.04.2015 | Ende: Q2 2019
Status: recruiting


Ixazomib in Combination with Thalidomide – Dexamethasone in patients with relapsed and/or refractory multiple myeloma

Studiendesign

This is an open phase II, single-arm, multi-center study to evaluate progression free survival in patients receiving ixazomib in combination with thalidomide and dexamethasone (ITD) followed by an ixazomib maintenance phase of a maximum period of 12 months.
The patient population will consist of adult male and female patients with multiple myeloma (MM) with relapsed and/or refractory disease after at least one prior treatment line.
In case of enrollment patients will receive ixazomib 4.0mg at days 1, 8, 15, thalidomide 100mg at days 1 to 28 (50mg in patients aged ≥75 years), and dexamethasone 40mg (20mg in patients aged ≥75 years) at days 1, 8, 15 of a 28-day treatment cycle. The proposed number of cycles is 8. Treatment will be discontinued in case of progressive disease or in case of no response after 4 cycles (≤ SD after 4 cycles). After discontinuation of therapy an end of treatment visit (EOT) will be performed within 14 days after the last dose of the last combination treatment cycle.
After 8 cycles of ITD therapy, maintenance treatment with 4.0mg ixazomib (3.0mg in patients aged ≥ 75 years at first day of maintenance phase) on days 1, 8, 15 of 28-day cycles will be administered to patients with ≥ MR for a maximum period of 12 months. Patients who completed less than 8 cycles of ITD treatment do not qualify for maintenance phase.
Follow-up visits will be performed in 3-monthly intervals until the last patient on ixazomib maintenance therapy has concluded or discontinued the maintenance phase.
A safety analysis will be conducted after enrollment of the first 6 patients and completion of at least two cycles in every patient.

Studienziele

Primary
• To determine progression-free survival in patients with relapsed/refractory multiple myeloma receiving ixazomib in combination with thalidomide and dexamethasone for 8 cycles followed by an ixazomib maintenance phase of a maximum period of 12 months.

Secondary
• To determine overall response rate (ORR) in patients with relapsed/refractory multiple myeloma receiving ixazomib in combination with thalidomide and dexamethasone followed by an ixazomib maintenance phase of a maximum period of 12 months. ORR will be assessed according to International Myeloma Working Group (IMWG) criteria, including Minor Response (MR) according to European Society for Blood and Bone Marrow Transplantation (EBMT) criteria
• To determine Overall Survival (OS) in patients with relapsed/refractory multiple myeloma receiving ixazomib in combination with thalidomide and dexamethasone followed by an ixazomib maintenance phase of a maximum period of 12 months.
• To determine renal response in a subgroup of patients with baseline GFR 15-30ml/min
• To assess safety and toxicity of the combination regimen ixazomib plus thalidomide plus dexamethasone followed by an ixazomib maintenance phase of a maximum period of 12 months.
• To assess prognostic value of risk factors at diagnosis, including clinical assessments, lab values and cytogenetic abnormalities such as translocations t(4;14), t(14;16), ampl1q, del17, del13
• To assess change of quality of life (QoL) of patients undergoing treatment with ixazomib plus thalidomide plus dexamethasone followed by an ixazomib maintenance phase of a maximum period of 12 months by use of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ C30/MY-20 module
• To associate possible correlations between altered expressions of specifically selected genes including methylation status of key genes (tumor suppressor, oncogenes, DNA repair, cell cycle control and other) and their response to the treatment regimen detected by gene expression profiling and methylation assays obtained at screening

Einschlusskriterien (Auszug)

- Male or female patients 18 years or older
- Patients in need of therapy with a diagnosis of relapsed or refractory multiple myeloma who had at least one prior treatment line (induction + autologous SCT + con-solidation + maintenance therapy = 1 therapy line)
- Patients must have measurable disease defined by at least 1 of the following criteria:
•Serum M-protein ≥ 10g/l
•Urine M-protein ≥ 200mg/24h
•Serum free light chain assay: involved serum light chain ≥ 10mg/dl provided that free light chain ration is abnormal
- ECOG ≤ 2
- Disease free of prior malignancies for ≥ 2 years
- Adequate hematology, liver and renal function:
Hematologic:
ANC (absolute neutrophil count) ≥ 1.0 x 109/L
Platelets ≥ 50 x 109/L
Liver Function:
GFR ≥ 15 ml/min
Serum bilirubin ≤ 2 x ULN
AST and ALT ≤ 3 x ULN ≤ 5 x ULN if documented liver metastases
Renal Function:
Serum Creatinine ≤ 1.5 mg/dL OR Calculated Creatinine Clearance ≥ 40 mL/min

Öffentliche Downloads

AGMT_MM-1/ EMN-13 Poster
Poster am OeGHO 2017



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HO95/EMN02

Coordinating Investigator: Prof. Dr. Pieter Sonneveld, Prof. Dr. Heinz Ludwig (Österreich)
Fallzahl: 1500
Start: Q2 2012 | Ende: Q3 2023
Status: active, not recruiting


A randomized phase III study to compare Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed by Bortezomib, Lenalidomide, Dexamethasone (VRD) consolidation and Lenalidomide maintenance in patients with newly diagnosed multiple myeloma

Studiendesign

Patients with multiple myeloma, meeting all eligibility criteria will be registered on entry and treated with 3 induction cycles with VCD, followed by Cyclophosphamide for stem cell mobilization and collection.
After induction patients will be randomized to compare two intensification regimens VMP vs. HDM (R1), except if a patient will proceed to allogenic SCT. In hospitals with a policy of double intensification, all patients will be randomized at R1 between VMP, 1 HDM and 2 HDM, in order also to evaluate 1 HDM vs. 2 HDM
After intensification treatment there will be a 2nd randomization to compare VRD consolidation vs. no consolidation (R2), followed by Lenalidomide maintenance in both arms.

Studienziele

Primary Endpoint:
• For all registered patients: progression free survival (PFS) as defined by time from registration to progression or death from any cause (whichever occurs first)
• For all patients included in R1; PFS as defined by time from randomization R1 to progression or death from any cause whichever comes first
• For all patients included in R2; PFS as defined by time from randomization R2 to progression or death from any cause whichever comes first

Secondary Endpoints:
• Response (PR, VGPR, CR and stringent CR), and improvement of response during the various stages of the treatment
• Overall survival measured from the time of registration/randomization R1/ randomization R2
Patients still alive or lost to follow up are censored at the date they were last known to be alive
• Toxicity

Einschlusskriterien (Auszug)

• Patients with a confirmed diagnosis of symptomatic multiple myeloma stage I to III according to the International Staging System ISS, i.e. at least one of the CRAB criteria should be present
• Measurable disease as defined by the presence of M-protein in serum or urine, or abnormal free light chain ratio
• Age 18-65 years inclusive
• WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by co-morbid conditions)
• Negative pregnancy test at inclusion if applicable
• Written informed consent

Öffentliche Downloads

HOVON Folder
Brief description of the HOVON Study



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