Study of Bendamustine, Velcade and Dexamethasone in the Treatment of Elderly Patients With Multiple Myeloma
NCT ID: NCT01045681
Last Updated: 2020-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2010-03-03
2013-03-28
Brief Summary
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The estimation of the efficacy rate is to be based on an explorative pilot study, since immediate embarking on a large-scale comparative efficacy trial would not be acceptable from the point of view of resources. Moreover, this would induce ethical objections, as it does not seem to be justifiable to expose a large number of patients to an experimental approach without sufficient exploratory indications of an improved risk-benefit ratio.
Detailed Description
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Bendamustine and bortezomib have shown high activity boch in first-line regimens and pre-treated patients. The novel mechanism of action of the proteasome inhibitor and the non-cross resistance of bendamustine to other alkylating agents established in the first-line treatment of multiple myeloma seem to recommend a combination of the two drugs for salvage therapy (second-line regimen). Finally, the promising response data in a series of relapsing MM patients treated with bendamustine, bortezomib and prednisone support this assumption, as well as the feasibility and tolerability of the combination.
In summary, there is some evidence for a favorable risk/benefit ratio for the combination of bendamustine, bortezomib and a corticoid drug, warranting the exploration in a larger, prospectively designed multicenter phase II study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BVD
Bendamustine, Velcade and Dexamethasone
Bendamustine, Velcade and Dexamethasone
Bendamustine : 70 mg/m2 iv on D1 and 8, for each cycle Velcade : 1.3 mg/m2 iv on D1, 8, 15 and 22, for each cycle Dexamethasone : 20 mg/day po on D1, 8, 15 and 22, given prior to Bendamustine and Velcade
Interventions
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Bendamustine, Velcade and Dexamethasone
Bendamustine : 70 mg/m2 iv on D1 and 8, for each cycle Velcade : 1.3 mg/m2 iv on D1, 8, 15 and 22, for each cycle Dexamethasone : 20 mg/day po on D1, 8, 15 and 22, given prior to Bendamustine and Velcade
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient having received conventional chemotherapy in 1st line treatment because of age 65 years or over, or younger than 65 years and ineligible to high-dose therapy plus stem cell transplantation.
* Measurable disease (≥10g/L monoclonal gammapathy and/or ≥ 200 mg/24h proteinuria or involved serum free light chain ≥ 100mg/L with abnormal FLC ratio \< 0.26 or \> 1.65)
* Patient in 1st relapse or refractory to 1st line therapy. Relapse is defined by M-component increase of ≥25% from baseline, in serum and/or urine (the absolute increase in serum must be ≥ 5 g/l - the absolute increase of BJ proteins in urine must be ≥200 mg/24 h). (It is recommended to treat only symptomatic or rapidly evolutive relapses)
* Life expectancy of at least 3 months
* ECOG performance status \<= 2 at study entry
* Laboratory test results within these ranges:
* Absolute neutrophil count \>= 1.5 x 109/L
* Platelet count \>= 100 x 109/L
* Serum creatinine \<= 250 umol/l
* AST (SGOT) and ALT (SGPT) \<= 3 x ULN
* Disease free of prior malignancies for \>= 5 years, with exception of curatively treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
* Able to adhere to the study visit schedule and other protocol requirements
* Using effective contraceptive methods during and for 6 months after study treatment (for fertile men, women of childbearing potential).
* Provision of informed consent.
* A period of at least 15 days must be respected between the last treatment of myeloma and the beginning of the study.
Exclusion Criteria
* Any comorbidity which places the subject at unacceptable risk if he/she were to participate in the study.
* Patients treated with high-dose therapy plus stem cell transplantation in 1st line therapy
* Any prior use of bortezomib (Velcade) or bendamustine (Ribomustin)
* Concurrent use of other anti-cancer agents or treatments other than those stated in this treatment plan
* Use of any other experimental drug or therapy within 28 days prior to the start of study treatment.
* Known hypersensitivity to the study drugs
* Positive HIV serology, positive hepatitis C serology, active infection hepatitis A, active infection hepatitis B.
* Severe cardiovascular disorders within 12 months prior to the start of study treatment (e.g. myocardial infarct, ischemic episodes, arrhythmias)
* Previous major surgery less than 30 days before start of treatment
* Active infection,
* Pregnant or lactating women.
65 Years
ALL
No
Sponsors
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Intergroupe Francophone du Myelome
NETWORK
Responsible Party
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Principal Investigators
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Philippe RODON, Doctor
Role: PRINCIPAL_INVESTIGATOR
Unité Hématologie Biologique Institut Curie PARIS
Cyrille HULIN, Doctor
Role: PRINCIPAL_INVESTIGATOR
Service Hématologie Hôpitaux de Brabois VANDOEUVRE LES NANCY
Jean-Luc HAROUSSEAU, Professor
Role: STUDY_DIRECTOR
Service Hématologie CHU Nantes
Claire MATHIOT, Doctor
Role: STUDY_CHAIR
IFM Hématologie Biologique Institut Curie PARIS
Marie-Odile PETILLON, Doctor
Role: STUDY_CHAIR
IFM Hôpital Claude Huriez Lille
Locations
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Hôpital de l'Archet 1
Nice, , France
Intitut Curie
Paris, , France
CHU Hôpital St-Antoine
Paris, , France
Centre Hopsitalier Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier René Dubos
Pontoise, , France
Centre Hospitalier de la Région d'Annecy
Pringy, , France
CHU Reims Hôpital R.Debré
Reims, , France
CHRU - Hôpital sud
Rennes, , France
Centre Jean Bernard
Le Mans, , France
CHRU Hôpital Claude Huriez
Lille, , France
Institut Paoli Calmette
Marseille, , France
CH MEAUX
Meaux, , France
CHRU Hôtel Dieu
Nantes, , France
CHRU Hôpital Sud
Amiens, , France
CHRU, Hôpital du Bocage
Angers, , France
Centre Hospitalier H.Duffaut
Avignon, , France
Centre Hospitalier de la Cote Basque
Bayonne, , France
Hôpital Jean Minjoz / CHU BESANCON
Besançon, , France
Centre Hospitalier
Blois, , France
Hôpital Avicenne
Bobigny, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Hôpital A.Morvan
Brest, , France
Centre F.Baclesse
Caen, , France
CHU Clermont Ferrand
Clermont-Ferrand, , France
CH Sud Francilien
Corbeil-Essonnes, , France
CHU DIJON, Hôpital Le Bocage
Dijon, , France
Centre Hospitalier Général
Dunkirk, , France
Hôpital A.Michallon
Grenoble, , France
CH Départemental
La Roche-sur-Yon, , France
Centre Hospitalier de Chartres
Le Coudray, , France
Centre Henri Becquerel
Rouen, , France
Centre René Huguenin
Saint-Cloud, , France
CHRU Hopital Purpan
Toulouse, , France
CHRU Hopital Bretonneau
Tours, , France
Centre Hospitalier
Valence, , France
CHRU - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, , France
CH P.Chubert
Vannes, , France
Countries
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References
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Rodon P, Hulin C, Pegourie B, Tiab M, Anglaret B, Benboubker L, Jardel H, Decaux O, Kolb B, Roussel M, Garderet L, Leleu X, Fitoussi O, Chaleteix C, Casassus P, Lenain P, Royer B, Banos A, Benramdane R, Cony-Makhoul P, Dib M, Fontan J, Stoppa AM, Traulle C, Vilque JP, Petillon MO, Mathiot C, Dejoie T, Avet-Loiseau H, Moreau P. Phase II study of bendamustine, bortezomib and dexamethasone as second-line treatment for elderly patients with multiple myeloma: the Intergroupe Francophone du Myelome 2009-01 trial. Haematologica. 2015 Feb;100(2):e56-9. doi: 10.3324/haematol.2014.110890. Epub 2014 Nov 14. No abstract available.
Other Identifiers
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Eudract 2009-012359-91
Identifier Type: REGISTRY
Identifier Source: secondary_id
IFM2009-01
Identifier Type: -
Identifier Source: org_study_id