Study of Bendamustine, Velcade and Dexamethasone in the Treatment of Elderly Patients With Multiple Myeloma
BVD
A Phase II Study of Bendamustine, Velcade and Dexamethasone (BVD) in the Treatment of Elderly Patients (>= 65 Years) With Multiple Myeloma in 1st Relapse or Refractory to 1st Line Therapy
2 other identifiers
interventional
75
1 country
37
Brief Summary
The present trial is designed as a phase II study that aims at estimating the efficacy of the combination of bendamustine, bortezomib and dexamethasone in relapsed/refractory multiple myeloma (MM). The response rate, i.e. the rate of the patients achieving a Complete Response or Partial Response at cycle 4, divided by the total intent to treat patient number is chosen as primary efficacy endpoint. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-myeloma
Started Mar 2010
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2010
CompletedFirst Posted
Study publicly available on registry
January 11, 2010
CompletedStudy Start
First participant enrolled
March 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2013
CompletedDecember 7, 2020
March 1, 2012
3.1 years
January 7, 2010
December 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess of the overall response rate (complete response (CR) + partial response (PR))
After four 28-day consecutives cycles
Secondary Outcomes (6)
Time to best response
the time from treatment start to the first detection of the best response category, calculated for all patients, which are not primarily refractory
Progression-free survival
The time form the initial dose of chemotherapy to the time of disease progression or death, or to the date of last assessment without any such event (censored observation)
Time to progression
The time from baseline to the development of progressive disease
Overall survival
The time interval from initial dose to the date of death or last observation (censored)
Rate of additional response
Following 2 consolidation cycles and following 6 maintenance cycles
- +1 more secondary outcomes
Study Arms (1)
BVD
EXPERIMENTALBendamustine, Velcade and Dexamethasone
Interventions
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
Eligibility Criteria
You may qualify if:
- Symptomatic multiple myeloma (MM) patient at the time of diagnosis (but not necessarily at the time of relapse), according to International Myeloma Working Group 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.
- +1 more criteria
You may not qualify if:
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
CHRU Hôpital Sud
Amiens, 80054, France
CHRU, Hôpital du Bocage
Angers, 49033, France
Centre Hospitalier H.Duffaut
Avignon, 84902, France
Centre Hospitalier de la Cote Basque
Bayonne, 64109, France
Hôpital Jean Minjoz / CHU BESANCON
Besançon, 25030, France
Centre Hospitalier
Blois, 41016, France
Hôpital Avicenne
Bobigny, 93009, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33000, France
Hôpital A.Morvan
Brest, 29609, France
Centre F.Baclesse
Caen, 14076, France
CHU Clermont Ferrand
Clermont-Ferrand, 63003, France
CH Sud Francilien
Corbeil-Essonnes, 91106, France
CHU DIJON, Hôpital Le Bocage
Dijon, 21034, France
Centre Hospitalier Général
Dunkirk, 59385, France
Hôpital A.Michallon
Grenoble, 38043, France
CH Départemental
La Roche-sur-Yon, 85925, France
Centre Hospitalier de Chartres
Le Coudray, 28629, France
Centre Jean Bernard
Le Mans, 72000, France
CHRU Hôpital Claude Huriez
Lille, 59038, France
Institut Paoli Calmette
Marseille, 13273, France
CH MEAUX
Meaux, 77104, France
CHRU Hôtel Dieu
Nantes, 44035, France
Hôpital de l'Archet 1
Nice, 06202, France
Intitut Curie
Paris, 75005, France
CHU Hôpital St-Antoine
Paris, 75571, France
Centre Hopsitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Hospitalier René Dubos
Pontoise, 95300, France
Centre Hospitalier de la Région d'Annecy
Pringy, 74374, France
CHU Reims Hôpital R.Debré
Reims, 51032, France
CHRU - Hôpital sud
Rennes, 35056, France
Centre Henri Becquerel
Rouen, 76038, France
Centre René Huguenin
Saint-Cloud, 92210, France
CHRU Hopital Purpan
Toulouse, 31059, France
CHRU Hopital Bretonneau
Tours, 37044, France
Centre Hospitalier
Valence, 26953, France
CHRU - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54511, France
CH P.Chubert
Vannes, 56017, France
Related Publications (1)
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.
PMID: 25398832DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe RODON, Doctor
Unité Hématologie Biologique Institut Curie PARIS
- PRINCIPAL INVESTIGATOR
Cyrille HULIN, Doctor
Service Hématologie Hôpitaux de Brabois VANDOEUVRE LES NANCY
- STUDY DIRECTOR
Jean-Luc HAROUSSEAU, Professor
Service Hématologie CHU Nantes
- STUDY CHAIR
Claire MATHIOT, Doctor
IFM Hématologie Biologique Institut Curie PARIS
- STUDY CHAIR
Marie-Odile PETILLON, Doctor
IFM Hôpital Claude Huriez Lille
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2010
First Posted
January 11, 2010
Study Start
March 3, 2010
Primary Completion
March 28, 2013
Study Completion
March 28, 2013
Last Updated
December 7, 2020
Record last verified: 2012-03