AzTrials
AzTrials

Multiple MyelomaPhase 2BVDNCT01045681

Study of Bendamustine, Velcade and Dexamethasone in the Treatment of Elderly Patients With Multiple Myeloma

A Phase 2 study testing Bendamustine, Velcade and Dexamethasone in people with Multiple Myeloma, run by Intergroupe Francophone du Myelome at 37 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Bendamustine, Velcade and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
37 sitesFrance
Study dates
3 Mar 2010to 28 Mar 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

France37 sites

  • CHRU Hôpital Sud

    Amiens, 80054

  • CHRU, Hôpital du Bocage

    Angers, 49033

  • Centre Hospitalier H.Duffaut

    Avignon, 84902

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64109

  • Hôpital Jean Minjoz / CHU BESANCON

    Besançon, 25030

  • Centre Hospitalier

    Blois, 41016

  • Hôpital Avicenne

    Bobigny, 93009

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33000

  • Hôpital A.Morvan

    Brest, 29609

  • Centre F.Baclesse

    Caen, 14076

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63003

  • CH Sud Francilien

    Corbeil-Essonnes, 91106

  • CHU DIJON, Hôpital Le Bocage

    Dijon, 21034

  • Centre Hospitalier Général

    Dunkirk, 59385

  • Hôpital A.Michallon

    Grenoble, 38043

  • CH Départemental

    La Roche-sur-Yon, 85925

  • Centre Hospitalier de Chartres

    Le Coudray, 28629

  • Centre Jean Bernard

    Le Mans, 72000

  • CHRU Hôpital Claude Huriez

    Lille, 59038

  • Institut Paoli Calmette

    Marseille, 13273

  • CH MEAUX

    Meaux, 77104

  • CHRU Hôtel Dieu

    Nantes, 44035

  • Hôpital de l'Archet 1

    Nice, 06202

  • Intitut Curie

    Paris, 75005

  • CHU Hôpital St-Antoine

    Paris, 75571

  • Centre Hopsitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier René Dubos

    Pontoise, 95300

  • Centre Hospitalier de la Région d'Annecy

    Pringy, 74374

  • CHU Reims Hôpital R.Debré

    Reims, 51032

  • CHRU - Hôpital sud

    Rennes, 35056

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre René Huguenin

    Saint-Cloud, 92210

  • CHRU Hopital Purpan

    Toulouse, 31059

  • CHRU Hopital Bretonneau

    Tours, 37044

  • Centre Hospitalier

    Valence, 26953

  • CHRU - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

  • CH P.Chubert

    Vannes, 56017

Other trials in France

About this study

Official title: 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

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.

Read the detailed description

After relapse or after early progression on first-line treatment, the prognosis of multiple myeloma (MM) patients is unfavourable, and the search for new treatment regimens, including drugs with novel mechanisms of action is essential.

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.

Being tested
Bendamustine, Velcade and Dexamethasone
Keywords
Multiple Myeloma, Elderly patients, first relapse, refractory to first line therapy, Bendamustine Velcade Dexamethasone Association
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bendamustine, Velcade and DexamethasoneDrug

    Also called Robimustin : Bendamustine, Velcade : Bortezomib, 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

Study groups in NCT01045681
Study groupRoleWhat they receive
BVDExperimentalBendamustine, Velcade and Dexamethasone
Receives: Drug: Bendamustine, Velcade and Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess of the overall response rate (complete response (CR) + partial response (PR))

    Measured: After four 28-day consecutives cycles

Secondary outcomes (6)

  1. Time to best response

    Measured: the time from treatment start to the first detection of the best response category, calculated for all patients, which are not primarily refractory

  2. Progression-free survival

    Measured: 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)

  3. Time to progression

    Measured: The time from baseline to the development of progressive disease

  4. Overall survival

    Measured: The time interval from initial dose to the date of death or last observation (censored)

  5. Rate of additional response

    Measured: Following 2 consolidation cycles and following 6 maintenance cycles

  6. Toxicity/Adverse events

    Measured: From the time a signed and dated informed consent form is obtained until 60 days following the lase dose of study medication or until the start of a new subsequent antimyeloma therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2010 (estimated)
  2. Study start3 Mar 2010
  3. Primary completion28 Mar 2013
  4. Study completion28 Mar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01045681
Sponsor's protocol ID
IFM2009-01
Other IDs
Eudract 2009-012359-91
Acronym
BVD
Status last verified
Mar 2012
First submitted
7 Jan 2010
Last updated
7 Dec 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25398832

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine, Velcade and Dexamethasone in people with Multiple Myeloma, run by Intergroupe Francophone du Myelome at 37 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess of the overall response rate (complete response (CR) + partial response (PR)) (time frame: After four 28-day consecutives cycles). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01045681, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in