Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Bortezomib

Dexamethasone acetate

Panobinostat

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Panobinostat was administered 3x week ( 2 weeks on 1 week off)

Bortezomib was administered 2 x week ( 2weeks on 1 week off)

Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration

Placebo was administered 3x week ( 2 weeks on 1 week off)

Placebo

Novartis Pharmaceuticals

Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile.

Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

Best overall response based on mEBMT criteria per investigator assessment

Higher values in the disease symptoms and side effects of treatment scores indicate worsening. Higher scores in the future perspective and body image scores indicate improvement. LS Means and SEM are estimated from the repeated measures model. Following factors and covariates are included in the repeated measurement model: time, treatment, treatment by time interaction, number of prior lines of anti-MM therapy (1/ 2 and 3), prior use of BTZ (Yes/ No), baseline score.Disease Symptom is the sum of 20 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome)", All subscales of EORTC QLQ-MY20 have the same score range of 0 -100. Decrease in symptom scores from baseline indicate improvement in symptoms.

The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), six single-item symptom scales (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. Disease Symptom is the sum of 30 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome)", All subscales of EORTC QLQ-C30 have the same score range of 0 -100. For global health status and other functional scales,an increase from baseline indicates improvement of QoL. Whereas for symptoms scales, fatigue, dyspnea, insomnia, appetite loss, constipation and diarrhea, decrease in scores from baseline indicate improvement in symptoms.

Chronic Illness Therapy (FACIT) Measurement System and focuses on four general quality of life domains for physical well being, functional well-being, social/family well-being, and emotional well-being, and includes additional items to characterize treatment-related neurotoxicity. Higher subscales/total scores represent higher QOL. In the case of the neurotoxicity subscale, lower scores correspond to higher neurotoxicity. The recall period referenced in the questionnaire is the past 7 days.Ranges for FACT-G subscales are as follows:.PWB, scale 0 -28, , NtxS scale 0-44, FACT/GOG-Ntx trial outcome index scale is 0-100 and FACT-G scale is also scaled 0-100. An increase from baseline in these scores indicate improvement.

Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.

PAN+BTZ

Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day..

PBO+BTZ

Panobinostat + Bortezomib

Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

Placebo + Bortezomib

Total

Age, Continuous

Sex: Female, Male

Caucasian

Asian

Black

Other

Race/Ethnicity, Customized

Study Director

Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone

Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Duration of Response Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Time to Progression/Relapse Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Disease Symptom wk 12 change baseline (n=215,243)

Disease Symptom wk 24 change baseline (n=148,177)

Disease Symptom wk 48 change baseline (n=37,26)

Side effects of treatment wk 12 chge (n=213,242)

Side effects of treatment wk 24 chge (n=148,175)

Side effects of treatment wk 48 chge (n=37,26)

Future perspective wk 12 chge (n=214,242)

Future perspective wk 24 chge (n=148,176)

Future perspective wk 48 chge (n=37,26)

Body image wk 12 chge (n=213,240)

Body image wk 24 chge (n=147,175)

Body image wk 48 chge (n=37,26)

European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group

Global health wk 12 change baseline (n=216,239)

Global health wk 24 change baseline (n=150,176)

Global health wk 48 change baseline (n=38,26)

Physical functioning wk 12 chge (n=217,242)

Physical functioning wk 24 chge (n=151,177)

Physical functioning wk 48 chge (n=38,26)

Role functioning wk 12 chge (n=215,237)

Role functioning wk 24 chge (n=150,176)

Role functioning wk 48 chge (n=38,26)

Cognitive functioning wk 12 chge (n=216,240)

Cognitive functioning wk 24 chge (n=149,176)

Cognitive functioning wk 48 chge (n=38,26)

Social functioning wk 12 chge (n=216,240)

Social functioning wk 24 chge (n=148,171)

Social functioning wk 48 chge (n=37,26)

Fatigue wk 12 chge (n=217,241)

Fatigue wk 24 chge (n=151,176)

Fatigue wk 48 chge(n=38,26)

Dyspnea wk 12 chge (n=217,240)

Dyspnea wk 24 chge (n=151,177)

Dyspnea wk 48 chge (n=38,26)

Insomnia wk 12 chge (n=216,239)

Insomnia wk 24 chge (n=149,176)

Insomnia wk 48 chge (n=38,26)

Appetite loss wk 12 chge (n=217,239)

Appetite loss wk 24 chge (n=151,176)

Appetite loss wk 48 chge (n=38,26)

Constipation wk 12 chge (n=215,240)

Constipation wk 24 chge (n=151,177)

Constipation wk 48 chge (n=38,25)

Diarrhea wk 12 chge (n=217,241)

Diarrhea wk 24 chge (n=150,177)

Diarrhea wk 48 chge (n=38,26)

European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group

Neurotoxicity wk 12 change baseline (n=212,240)

Neurotoxicity wk 24 change baseline (n=148,174)

Neurotoxicity wk 48 change baseline (n=35,26)

Physical wellbeing wk 12 chge (n=215,240)

Physical wellbeingwk 24 chge (n=150,176)

Physical wellbeing wk 48 chge (n=38,26)

Trial Outcomes wk 12 chge (n=209,236)

Trial Outcomes wk 24 chge (n=148,173)

Trial Outcomes wk 48 chge (n=35,26)

FACT-G Total wk 12 chge (n=213,240)

FACT-G Totalwk 24 chge (n=147,175)

FACT-G Total wk 48 chge (n=37,26)

FACT/GOGNTX Total wk 12 chge (n=206,230)

FACT/GOGNTX Total wk 24 chge (n=146,172)

FACT/GOGNTX Total wk 48 chge (n=35,26)

Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group

Overall Study

Antirheumatic Agents

Anti-Infective Agents

Cyclophosphamide

Thalidomide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

Arm A:

1. Induction therapy 4 cycles of VTD (21 days) Thalidomide® 100 mg/day Per Os Day1 to Day21 Velcade® 1.3 mg/m²/day Subcutaneous Day1, 4, 8 and 11 Dexamethasone 40 mg/day Per Os Day 1 to 4 and Day 9 to 12
2. Systematic stem cell harvest after cycle 3 Mobilization: Cyclophosphamide and one week after the last dose of Thalidomide, stem cells have to be harvested

For arm B:

1. Induction therapy : 4 cycles of VCD (21 days)

   * Cyclophosphamide 500 mg/m²/day, Per Os Day 1, 8, 15
   * Velcade® and Dexamethasone identical treatment to Arm A
2. Systematic stem cell harvest after cycle 3 Mobilization: Cyclophosphamide and two weeks after the last dose of Cyclophosphamide, stem cells have to be harvested

Thalidomide®

Velcade®

Dexaméthasone

Philippe MOREAU

This is a phase III, multicenter, prospective with a clinical benefit, open-label and randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly Diagnosed Multiple Myeloma.

Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4 consecutive 21 day cycles of an induction treatment with either VTD or VCD.

The patient population will consist of adult men and women who have a confirmed diagnosis of Multiple Myeloma and who meet eligibility criteria. They will be recruited from among the patients consulting in an investigating centre's haematology service for newly diagnosed, symptomatic, untreated multiple myeloma.

in each treatment arm there will be :

1. Induction therapy : 4 cycles of VTD (21 days)or VCD
2. Systematic stem cell harvest after cycle 3

Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04)

A PHASE III STUDY OF VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD) VERSUS VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD) AS AN INDUCTION TREATMENT PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA."

The detection and the estimation of the urinary monoclonal components is an inescapable element of the diagnosis and the evaluation of the therapeutic efficacy in the myeloma.

Urinary protein, electrophoresisin agarose gel is the quantitative method of choice. In these labs, the quantification of the urinary monoclonal peak is not performed. In the absence of quantitative data on urinary monoclonal components, the patient is considered as non-assessable. Recently, the company Sebia has developed the quantification on two other materials used specifically for the characterization of monoclonal component and / or proteinuria (HYDRAGEL BENCE JONES and HYDRAGEL URINE PROFILE).

The objective of this study is to compare the quantification of monoclonal components between the reference HR electrophoresis technique and the other two above-mentioned techniques.

compare the Response assessment in both arms: the Very good partial remission rate (according to the criteria IMWG) achieved with four courses of VTD with that achieved with four courses of VCD

compare the Response assessment in both arms: the following parameters after induction treatment with four courses of VTD or four courses of VCD the Complete remission rate (according to the criteria IMWG)

To evaluate the Safety of induction therapy

To evaluate Overall and Progression-Free Survival

compare the Response assessment in both arms: Compare the following parameters after induction treatment with four courses of VTD or four courses of VCD the Partial remission rate (according to the criteria IMWG)

Nantes University Hospital

Doxorubicin

Liposomal doxorubicin

Vincristine

Velcade

Jean-Luc Harousseau, MD PHD

This is an open-label, multi-centre, randomised Phase III study, looking at a series of 480 patients up to the age of 65 with newly diagnosed multiple myeloma (MM) not previously treated. They will receive VAD or Velcade®/dexamethasone combination as induction treatment plus/minus (±) dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) followed by autograft as first-line therapy, as the investigators try to compare the complete remission (CR) rate (with negative or positive immunofixation) at the end of their induction treatment.

After their written informed consent has been obtained and their eligibility verified, patients are randomised between 4 treatment arms: A1 VAD (4 cycles); A2 VAD (4 cycles) followed by DCEP (2 cycles); B1 Velcade® + dexamethasone (4 cycles); B2 Velcade® + dexamethasone (4 cycles) followed by DCEP (2 cycles) A1, A2, B1, B2 + autograft. Randomisation will be stratified on the basis of the initial b2 microglobulin level (\> or \< 3 mg/l) and the presence of chromosome 13 abnormalities identified by FISH analysis. VAD: Vincristine/Adriamycin/Dexamethasone; DCEP: Dexamethasone/Cyclophosphamide/ Etoposide/Cisplatin.

IFM 2005-01: Velcade/Dexamethasone Versus Vincristine/Adriamycin (Doxorubicin)/Dexamethasone (VAD) for the Treatment of Patients With Multiple Myeloma

Etude Multicentrique Ouverte Randomisée de Phase III Comparant l'Association de VELCADE®-Dexaméthasone à la Chimiothérapie de Type VAD Pour le Traitement Des Patients Porteurs de Myélome Multiple de Novo Jusqu'à l'âge de 65 Ans

Lymphoma

Lymphoma, Non-Hodgkin

Lymphoma, B-Cell

Lymphatic Diseases

B-cell Lymphoma

Lymphosarcoma

Rituximab

BB 1101

Antineoplastic Agents, Immunological

Velcade 375 mg/m\^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.

1.6 mg/m\^2 of Velcade® given intravenously on days 1, 8, 15 and 22.

VELCADE®

375 mg/m\^2 of Rituximab given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.

400 mg/m\^2 of Cyclophosphamide given orally on days 1-4 of each cycle.

40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23

Decadron

Chadi Nabhan, MD

Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.

This is a phase II open label study that is looking at the VRCD combination regimen in patients with previously untreated low-grade Non-Hodgkin's Lymphoma. Treatment will start by combining oral dexamethasone and cyclophosphamide with intravenous VELCADE, rituximab. Chemotherapy cycles will be given as outlined below every 35-days and will continue until two cycles beyond complete remission (CR), toxicity, patient's withdrawal, disease progression, or a maximum of 8 cycles.

VELCADE,Rituximab,Cyclophosphamide and Decadron

Phase II Study Investigating the Efficacy of VELCADE®, Rituximab, Cyclophosphamide and Decadron (VRCD Regimen) in Front-line Therapy of Patients With Low-grade Non-Hodgkin's Lymphoma

Percentage of complete responders plus percentage of partial responders equals overall response rate.

The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma	NCT01023308	Multiple Myelom...	Panobinostat Bortezomib Dexamethasone Placebo	18 Years -	Novartis
Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04)	NCT01971658	Multiple Myelom...	Thalidomide® Cyclophosphamid... Velcade® Dexaméthasone	18 Years - 65 Years	Nantes University Hospital
Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma	NCT01023308	Multiple Myelom...	Panobinostat Bortezomib Dexamethasone Placebo	18 Years -	Novartis
IFM 2005-01: Velcade/Dexamethasone Versus Vincristine/Adriamycin (Doxorubicin)/Dexamethasone (VAD) for the Treatment of Patients With Multiple Myeloma	NCT00200681	Multiple Myelom...	Velcade	18 Years - 65 Years	Nantes University Hospital
VELCADE,Rituximab,Cyclophosphamide and Decadron	NCT00413959	Lymphoma, Non-H... Lymphoma, B-Cel...	VELCADE® Rituximab Cyclophosphamid... Decadron	18 Years - 90 Years	Oncology Specialists, S.C.
Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04)	NCT01971658	Multiple Myelom...	Thalidomide® Cyclophosphamid... Velcade® Dexaméthasone	18 Years - 65 Years	Nantes University Hospital
IFM 2005-01: Velcade/Dexamethasone Versus Vincristine/Adriamycin (Doxorubicin)/Dexamethasone (VAD) for the Treatment of Patients With Multiple Myeloma	NCT00200681	Multiple Myelom...	Velcade	18 Years - 65 Years	Nantes University Hospital
Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma	NCT01023308	Multiple Myelom...	Panobinostat Bortezomib Dexamethasone Placebo	18 Years -	Novartis

Spots Global Cancer Trial Database for velcade®

Every month we try and update this database with for velcade® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for velcade®

Every month we try and update this database with for velcade® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for velcade® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.