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Multiple MyelomaPhase 2BPVNCT02237261

Bendamustine, Prednisone and Velcade® for First-line Treatment of Patients With Symptomatic Multiple Myeloma

A Phase 2 study testing Bendamustine, Bortezomib, Prednisone in people with Multiple Myeloma, run by University Hospital Heidelberg at 15 sites in Germany.

Completed

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

Official record
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Trial summary

The purpose of this study is to improve efficacy of treatment for patients with newly diagnosed multiple myeloma who are not eligible for high-dose chemotherapy followed by autologous stem cell transplantation by Bendamustin, Bortezomib (Velcade), and Prednisone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Bendamustine, Bortezomib, Prednisone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
15 sitesGermany
Study dates
Nov 2014to Oct 2018
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed multiple myeloma requiring systemic treatment (according to CRAB criteria as specified in the appendix I) with following characteristics: Subject is not a candidate for high-dose chemotherapy and stem cell transplantation due to age, presence of comorbidities likely to have a negative impact on tolerability of HDT-SCT, or subject preference
  • Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements (Durie et al., 2006):
  • Serum M-protein ≥ 10g/l
  • Urine light-chain (M-protein) of ≥ 200 mg/24 hours
  • Serum FLC assay: involved FLC level ≥ 10 mg/dl provided sFLC ratio is abnormal
  • Age>18 years
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  • WHO performance status 0-3 (WHO=3 is allowed only when related to MM and not to co-morbid conditions) (see appendix III)
  • For women of childbearing potential: negative pregnancy test at inclusion
  • All patients must be willing and capable to use adequate contraception during the complete therapy.
  • All patients must agree to abstain from donating blood while on study
  • Ability to understand character and individual consequences of the clinical trial
  • Written informed consent (must be available before enrolment in the trial)

Who cannot join

  • Subjects presenting any of the following criteria will not be included in the trial
  • Patient has known hypersensitivity to bortezomib, bendamustine and prednisone or to any of the constituent compounds (incl. boron and mannitol).
  • Systemic AL amyloidosis (except for patients with AL amyloidosis of the skin or the bone marrow)
  • Chemotherapy or radiotherapy during the past 5 years except patients with local radiotherapy in case of local myeloma progression. (Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy within 3 weeks prior to study entry.)
  • Plasma cell leukemia which requires the presence of 20% of plasma cell in peripheral blood leukocytes and at least 2 plasma cells/nl.
  • Severe cardiac dysfunction (NYHA classification III-IV, see appendix III)
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  • Significant hepatic dysfunction (serum bilirubin ≥ 2 mg/dl or ASAT and/or ALAT ≥ 2.5 times normal level), unless related to myeloma
  • Patients known to be HIV-positive
  • Patients with active, uncontrolled infections
  • Patients with peripheral neuropathy or neuropathic pain of CTC grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0, see appendix V)
  • Second malignancy during the past 5 years except:
  • Adequately treated basal cell or squamous cell skin cancer, or
  • Carcinoma in situ of the cervix, or
  • Prostate cancer < Gleason score 6 with undetectable prostate-specific antigen (PSA) over 12 months, or
  • Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins), or
  • Similar malignant condition as a.- d. with an expected5-year disease free survival larger than 95% 11. Patients with acute diffuse infiltrative pulmonary and pericardial disease 12. Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia 13. Platelet count < 50 x 109/l (transfusion support within 14 days before the test is not allowed), unless related to myeloma 14. Hemoglobin < 7.5g/dl, unless related to myeloma 15. Absolute neutrophil count (ANC) < 0.75 x 109/l (the use of colony stimulating factors within 14 days before the test is not allowed), unless related to myeloma 16. Pregnancy and lactation 17. Participation in other clinical trials within one month prior to enrolment except for supportive care studies and vaccination studies. (Note: this does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months).
  • No subject will be allowed to enrol in this trial more than once.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Germany15 sites

  • Klinikum Aschaffenburg, Med. Klinik II

    Aschaffenburg, 63739

  • Hämatologisch-Onkologische gemeinschaftspraxis

    Augsburg, Bavaria, 86150

  • Onkologische Gemeinschaftspraxis

    Cologne, North Rhine-Westphalia, 50677

  • Onkologische Schwerpunktpraxis Dr. G. Kojouharoff

    Darmstadt, Hesse, 64295

  • Städtische Klinikum Dessau

    Dessau, Saxony-Anhalt, 06847

  • Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanienkrankenhaus

    Frankfurt am Main, Hesse, 60389

  • Agaplesion Markus Krankenhaus gGmbH, Medizinisches Versorgungszentrum

    Frankfurt am Main, Hesse, 60431

  • Onkologisches Ambulanzzentrum Hannover am Diakoniekrankenhaus Henriettenstift gGmbH

    Hannover, North Rhine-Westphalia, 30171

  • Onkologische Schwerpunktpraxis

    Heidelberg, Baden-Wurttemberg, 69115

  • Medizinische Klinik V, Universitätsklinikum Heidelberg, Sektion Multiples Myelom

    Heidelberg, Baden-Wurttemberg, 69120

  • Klinikum Idar-Oberstein GmbH, Innere Medizin I

    Idar-Oberstein, Rh-Pfalz, 55743

  • Mannheimer Onkologie Praxis

    Mannheim, Ba-Wü, 68161

  • Onkologische Praxis Oldenburg/Delmenhorst

    Oldenburg, 26121

  • Onkologische Schwerpunktpraxis Speyer

    Speyer, Rhineland-Palatinate, 67346

  • Gemeinschaftspraxis Dr. R. Schlag/Dr. B. Schöttker

    Würzburg, Bavaria, 97080

Other trials in Germany

About this study

Official title: Bendamustine, Prednisone and Velcade® for First-line Treatment of Patients With Symptomatic Multiple Myeloma Not Eligible for High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation (BPV).

The purpose of this study is to improve efficacy of treatment for patients with newly diagnosed multiple myeloma who are not eligible for high-dose chemotherapy followed by autologous stem cell transplantation by Bendamustin, Bortezomib (Velcade), and Prednisone.

Read the detailed description
  1. Objectives Primary -Therapeutic efficacy of BPV regimen for multiple myeloma as evidenced by the overall response defined as partial response (PR) or better Secondary
  • to assess overall survival (OS) and progression-free survival (PFS)
  • to determine response duration
  • to investigate improvements of renal function
  • to evaluate safety and toxicity (with respect to adverse events of CTCAE grade ≧3 and SAEs)
  • to analyze the efficacy for genetically defined subgroups of myeloma patients based on iFISH and gene-expression profiling
  1. Investigational Medicinal Products Bortezomib Bendamustine both in combination with Prednisone
Being tested
Bendamustine, Bortezomib, Prednisone
Keywords
Newly diagnosed symptomatic multiple myeloma
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, Bortezomib, PrednisoneDrug

    Also called Velcade (Bortezomib), Levact (Bendamustine)

    Cycle 1 (d1-42) - Induction:

    Bortezomib: 1.3 mg/m2 s.c.: d1, 4, 8, 11, 22, 25, 29, 32 Bendamustine: 90 mg/m2 iv, d1, 2 Prednison: : 60 mg/m2 po,, d1-4

    Cycle 2-9 (d1-28) - Consolidation:

    Bortezomib: 1.3 mg/m2 s.c.: d1, 8, 15, 22 Bendamustine: 90 mg/m2 iv: d1, 2 Prednison: 60 mg/m2 po: d1-4

Study groups in NCT02237261
Study groupRoleWhat they receive
Bendamustine, Bortezomib, PrednisoneExperimentalInduction: Bortezomib: 1.3 mg/m2 subcutaneous for 7 days and Bendamustine: 90 mg/m2 intravenous for 2 days and in addition Prednison: : 60 mg/m2 per os for 4 days Consolidation: Bortezomib: 1.3 mg/m2 subcutaneous for 4 days and Bendamustine: 90 mg/m2 intravenous for 2 days and in addition Prednison 60 mg/m2 per os for 4 days
Receives: Drug: Bendamustine, Bortezomib, Prednisone

What is being measured

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

  1. Overall Response Rate (ORR) of BPV

    ORR is defined as PR or better

    Measured: 2 years

Secondary outcomes (10)

  1. Number and percentage of patients achieving a complete response

    Number and percentage of patients achieving a complete response

    Measured: 2 years

  2. Progression-free survival (PFS)

    PFS defined as time from registration to progression or death whatever comes first

    Measured: 2 years

  3. Overall survival (OS)

    OS defined as time from registration to time of death from any cause.

    Measured: 2 years

  4. Time-to-progression (TTP)

    TTP defined as time from registration to disease progression. TTP is censored at time of deaths which are not caused by progression.

    Measured: 2 years

  5. Disease-free survival (DFS)

    DFS defined as time from start of CR to relapse or death from any cause whichever comes first. Patients evaluable for DFS are patients in complete Response.

    Measured: 2 years

  6. Duration of response (DOR)

    DOR defined as time from first observation of PR to the time of disease progression.

    Measured: 2 years

  7. Renal response according to IMWG (CRrenal, PRrenal, MRrenal)

    percent of patients with recovery/improvement of renal function (for patients with impared renal finction at baseline)

    Measured: 2 years

  8. Toxicity (with respect to adverse events of CTCAE grade ≧3 and SAEs)

    toxicity during study therapy with AE of CTC grade ≧ 3, as well as neuropathy of CTC grade 2, measured by CTC-AE (v4.0).

    Measured: 2 years

  9. Time to objective Response (TOR)

    TOR defined as time from registration to achieving an objective response for patients achieving an objective Response.

    Measured: 2 years

  10. Time to treatment failure (TTF)

    TTF is defined as time from registration to treatment discontinuation for any reason, including disease progression, Treatment toxicity, patient preference or death.

    Measured: 2 years

Timeline

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

  1. First posted11 Sep 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionOct 2018
  4. Study completionOct 2018

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
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02237261
Sponsor's protocol ID
BPV
Other IDs
2013-005485-19
Acronym
BPV
Status last verified
Oct 2020
First submitted
9 Jun 2014
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Knauf W, Dingeldein G, Schlag R, Welslau M, Moehler T, Terzer T, Walter S, Habermehl C, Kunz C, Goldschmidt H, Raab MS; BPV trial group. First-line therapy with bendamustine/prednisone/bortezomib-A GMMG trial for non-transplant eligible symptomatic multiple myeloma patients. Eur J Haematol. 2020 Aug;105(2):116-125. doi: 10.1111/ejh.13409. Epub 2020 May 26.

    PubMed 32155662

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine, Bortezomib, Prednisone in people with Multiple Myeloma, run by University Hospital Heidelberg at 15 sites in Germany.

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 12 inclusion and 17 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany. 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?

Overall Response Rate (ORR) of BPV (time frame: 2 years). 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 NCT02237261, 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 19 Oct 2020.

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