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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00256776
Other study ID # EudraCT: 2005-001628-35
Secondary ID EBMT-CLWP: 42206
Status Terminated
Phase Phase 3
First received
Last updated
Start date July 2005
Est. completion date December 2015

Study information

Verified date September 2021
Source European Society for Blood and Marrow Transplantation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an international study in adult patients diagnosed with multiple myeloma who have already received at least one autologous stem cell transplantation and who have responded but later progressed, or relapsed, at least one year after transplantation. Eligible patients will be randomly assigned to one of two treatments: either Velcade plus Thalidomide plus Dexamethasone or Thalidomide plus Dexamethasone. Thalidomide and Velcade are two new agents that have recently become available for the treatment of multiple myeloma, especially in relapsed patients. This study therefore aims to test the hypothesis that the combination treatment with Velcade plus Thalidomide plus Dexamethasone will result in a longer time to progression (measure of time after the disease is treated until it starts to get worse) than Thalidomide plus Dexamethasone alone.


Description:

Primary Objectives: * Test the hypothesis that treatment with Velcade plus Thalidomide plus Dexamethasone in combination, will result in a longer time to progression (TTP) than Thalidomide plus Dexamethasone in subjects with relapsed or progressive myeloma after autologous transplantation. Secondary Objectives: * Compare the treatment groups for: overall survival; response rate (complete & partial & minimal) using standard criteria and treatment related complications. Study design and methodology: This is a prospective, randomized, parallel-group, open-label phase III, on an intention to treat, multicenter study. The main endpoint is time-to-failure (TTP=time to progression). The power is based on an initial assumption of a median TTP of 1.5 years in the experimental (Velcade) group and 1 year in the control group. The design of the study is group sequential. There will be 4 interim analyses and one final analysis. The study is designed to have a priori 90% power to detect the clinically relevant difference at completion of the study at 0.025 level. Patients with multiple myeloma whose disease has either progressed or relapsed at least one year after one or two autologous transplantations will be enrolled. Prior to random assignment, subjects will be stratified on center and number of autologous transplants.Subjects will be randomly assigned to treatment in a 1: 1 allocation within each stratum to Velcade plus Thalidomide plus Dexamethasone (VTD) or Thalidomide plus Dexamethasone. Velcade 1.3 mg/m2 will be given as an i.v. bolus on Days 1, 4, 8 and 11 followed by a 10-day rest period (Days 12 to 21) for 8 cycles (6 months) and then on Days 1, 8, 15, and 22 followed by a 20-day rest period (Days 23 to 42) for 4 cycles (6 months). In both arms, Thalidomide will be given at 200 mg/day per os for one year and Dexamethasone 40 mg/day per os four days every three weeks for one year.Treatment will continue until disease progression, or the occurrence of unacceptable treatment-related toxicity, or up to a total of 12 cycles of Velcade except for those subjects who have a continuing decrease in the levels of paraprotein after 12 cycles. These subjects may continue for as long as treatment is tolerated, and they continue to respond. If a subject has a CR, then treatment should continue at least 2 cycles after the objective response is confirmed. For subjects with a PR or stable disease, treatment may continue after a maximum objective response is confirmed unless the subject experiences unacceptable treatment-related toxicity or the subject has completed 12 cycles of treatment. Disease assessment will occur at the start of each cycle. If a subject discontinues treatment without disease progression, disease assessment will be performed every 3 weeks for 48-weeks from the start of the first dose of study entry drug. Subjects who have not progressed at the end of 48-week follow up period will be assessed every 6 weeks until disease progression is documented


Recruitment information / eligibility

Status Terminated
Enrollment 269
Est. completion date December 2015
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female =18 years-of-age - Multiple myeloma with evaluable disease - Relapsing or having a progressive disease - Karnofsky performance status > 50 % - Life expectancy of at least 3 months - Female of child-bearing potential must have a method of birth control and a negative serum or urine beta--human chorionic gonadotropin (ß-HCG) pregnancy test at screening and all through the study - Male must use contraception - Voluntary written informed consent Exclusion Criteria: - Non-secretory multiple myeloma - Platelet count < 40,000 X 10^9/L - Absolute neutrophil count <1.0 X 10^9/L - Creatinine clearance <30 mL/minute - Peripheral neuropathy >= Grade 2 - Seropositive for HIV, or active hepatitis A, B or C infection - Pregnant or breastfeeding female - Patient has hypersensitivity to bortezomib, boron or mannitol - Other investigational drugs - Serious medical or psychiatric illness - Previous or concurrent malignancies at other sites - Poorly controlled hypertension, uncontrolled or severe cardiovascular disease or uncontrolled diabetes mellitus

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Velcade (Bortezomib)

Thalidomide

Dexamethasone


Locations

Country Name City State
Austria Karl-Franzens Graz
Austria Universitatsklinik Innsbruck
Austria Medizinische Universitaet Wien Vienna
Austria Wilhelminenspital Vienna
Belgium St Joseph Arlon
Belgium RHMS Baudour
Belgium AZ St Jan Brugge
Belgium Bordet Brussels
Belgium Erasme CHU Brussels
Belgium Saint Luc Brussels
Belgium University Hospital Brussels
Belgium Saint Joseph Gilly
Belgium CH Jolimont Haine-Saint-Paul
Belgium Clinique Saint-Pierre Ottignies
Belgium UCL Mont-Godinne Yvoir
Czechia University Hospital Brno
Czechia Faculty Hospital Olomouc
France CHU Amiens Amiens
France CHU Angers Angers
France Centre Hospitalier d'Antibes Antibes
France CHU Jean Minjoz Besancon
France Avicenne Bobigny
France Polyclinique Bordeaux Nord Bordeaux
France Morvan CHU Brest
France Hotel Dieu Clermont-Ferrand
France ARC CHU Dijon Dijon
France Hospitalier de Dunkerque Dunkerque
France Hopital Michallon Grenoble
France Centre Hospitalier du Havre Le Havre
France CHRU de Lille Lille
France Edouard Herriot Lyon
France Pierre Benite Lyon
France Centre Hospitalier de Mulhouse Mulhouse
France CHU Nancy Nancy
France Hotel Dieu Nantes
France Archet Nice
France Hopital Cochin Paris
France Hotel Dieu Paris
France Saint Antoine Paris
France Hopital Jean Bernard Poitiers
France Robert Debre Reims
France CHU Hopital Sud Rennes
France Henri Becquerel Rouen
France CHRU Tours Tours
Germany Klinikum Bremen Bremen
Germany University of Cologne Cologne
Germany University Hospital Dresden
Germany University Hospital Hamburg
Germany Medizinische Hochschule Hannover
Germany Uniklinik Leipzig Leipzig
Germany Universitatsklinikum Schleswig-Hostein Lubeck
Germany DKD Wiesbaden Wiesbaden
Germany Medizinische und Poliklinik II Wurzburg
Hungary St Laszlo Hospital Budapest
Hungary University of Debrecen Debrecen
Israel Rambam MC Haifa
Israel Sheba MC Tel Hashomer
Italy Ospedale SS. Antonio e Biagio e Cesare Arrigo Alessandria
Italy Ospedale Riuniti Bergamo
Italy AO Spedali Civili di Brescia Brescia
Italy Ospedale Maggiore Catania
Italy Ospedale Maggiore Milan
Italy Federico II Naples
Italy V. Cervello Palermo
Italy Azienda Ospedale BMM Reggio di Calabria
Italy A.O.S. Andrea Rome
Switzerland Kantonsspital Aarau Aarau
Switzerland Kantonsspital Baden Baden
Switzerland Kantonsspital Basel
Switzerland IOSI, Ospedale Civico Bellinzona
Switzerland Inselspital Bern
Switzerland Hopital Cantonal Universitaire Geneva
Switzerland CHUV Lausanne
Switzerland LA Onkologie/Medizin Thun
Switzerland Stadtdpital Triemli Zurich
Switzerland UniversitatsSpital Zurich
United Kingdom Heartlands Hospital Birmingham
United Kingdom Addenbrookes Cambridge
United Kingdom Great Western Hospital Swindon

Sponsors (3)

Lead Sponsor Collaborator
European Society for Blood and Marrow Transplantation Celgene Corporation, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Median Time to Progression (TTP) 3 year
Secondary Progression Free Survival 3 year
Secondary Overall Survival (Interval Between Date of Randomization and Death From Any Cause 1 year
Secondary Response Rate (Proportion of Subjects Who Achieve Complete, Partial, or Minimal Response) 1 year
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Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
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Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1

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