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Multiple MyelomaPhase 2NCT01376401

Bendamustine, Bortezomib (Velcade ®) and Prednisone (BVP) in Patients Newly Diagnosed Multiple Myeloma

A Phase 2 study testing Bendamustine, Velcade and Prednisone in people with Multiple Myeloma, run by PETHEMA Foundation at 14 sites in Spain.

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

This protocol corresponds to an open-label national phase II, multicenter, to assess efficacy (in terms of response rate and CR) and toxicity of bendamustine, bortezomib and prednisone (BVP) in 60 patients newly diagnosed MM. Read more about this study

Who is it for?
Any age
Conditions the study is for
Multiple Myeloma
What is being tested?
Bendamustine, Velcade and Prednisone
How many people
60 participants
Where
14 sitesSpain
Study dates
Jul 2011to Dec 2015
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient age greater than or equal to 18 at the time of signing Informed consent
  • Patient who has voluntarily signed informed consent before conduct of the trial any evidence that is not part of care normal patients, with the knowledge of the patient that can leave the trial at any time he want
  • Patient able, in the opinion of the physician to comply with the visitation schedule and other requirements of the protocol
  • Patient newly diagnosed symptomatic multiple myeloma based on standard criteria and has not received any previous treatment of chemotherapy for MM.
  • Patients with newly diagnosed multiple myeloma, secretory, or oligosecretor or not secretor if it has soft tissue plasmacytomas.
  • Patients with non-secretory MM oligosecretor or without white tissue plasmacytomas be excluded to keep a group of patients with characteristics similar to the previous study with which we compare the results.
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  • Patients with measurable disease, defined by the following criteria:
  • For MM secreting measurable disease is defined as any value quantifiable serum monoclonal protein (≥ 1g/dl) and where applicable, a light chain excretion in urine ≥ 200 mg/24 hours. For Multiple Myeloma oligosecretor or secreting measurable disease defined by the presence of soft tissue plasmacytomas (not bone) determined by clinical examination or radiographic methods (eg MRI, CT-Scan)
  • ECOG PS ≤ 2
  • Expectations of life than 3 months.
  • The patient has the following laboratory values within 28 days before the baseline visit:
  • Platelet count ≥ 100 x 109 / L, hemoglobin ≥ 8.0g/dL and absolute neutrophil count (ANC) ≥ 1.5 x 109 / L; allowed counts under if they are clearly due to a bone marrow infiltration by MM.
  • Corrected serum calcium <14mg/dL. Aspartate transaminase (AST) ≤ 2.5 x upper limit of normal(LSN) Alanine aminotransferase (ALT) ≤ 2.5 x ULN Total bilirubin within normal limits Serum creatinine <2 mg / dL
  • Patients of childbearing potential must use effective contraception during duration of the study and up to 6 months after completion of treatment

Who cannot join

  • Patient has previously received treatment for multiple myeloma with Pulse steroids except for some emergency that requires it before start of induction therapy, administration of bisphosphonates or radiation therapy, or analgesic due to the presence of plasmacytomas, which require it for some urgency.
  • Patients with non-measurable disease.
  • Patient with peripheral neuropathy grade ³ 2 within 14 days prior to its inclusion in the trial
  • Patients with hypersensitivity to bortezomib, boric acid, or bendamustine mannitol
  • Patient to be known carrier of the virus HIV (human immunodeficiency) surface antigen of hepatitis B virus or who has active infection virus hepatitis C.
  • Patient who has had a myocardial infarction within 6 months prior to inclusion in the clinical trial or has a functional class III or IV according to the New York Heart Association (NYHA) heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias or acute ischemia detected electrocardiographically or conduction system disorders.
Show all 14Show fewer
  • Patient who has received any investigational agent within 30 days prior their inclusion or is currently in another clinical trial or receiving any investigational agent
  • Patient undergoing major surgery within 30 days before inclusion in the study
  • Patient pregnant or breastfeeding
  • Patients with acute diffuse infiltrative pulmonary disease and / or disease pericardium
  • History of other malignancies after different myeloma (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) to unless the patient is free of the disease beyond 5 years
  • Hypertension arterial or poorly controlled diabetes mellitus or any other disease severe organ involving an unreasonable risk to the patient
  • Any psychiatric disorder that interferes with comprehension of consent informed or prevent the normal discharge that requires participation in this trial
  • Patients with major psychiatric history.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Spain14 sites

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona

  • Hospital Clínic

    Barcelona

  • Institut català d'Oncología

    Barcelona

  • Hospital 12 de Octubre

    Madrid

  • Hospital Clínico San Carlos

    Madrid

  • Hospital Universitario de la Princesa

    Madrid

  • Hospital Universitario Ramón y Cajal

    Madrid

  • MD Anderson Internacional

    Madrid

  • Hospital Universitario Virgen de la Victoria

    Málaga

  • Hospital General Morales Messeguer

    Murcia

  • Hospital Universitario Central de Asturias

    Oviedo

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Universitario La Fe

    Valencia

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza

Other trials in Spain

About this study

This protocol corresponds to an open-label national phase II, multicenter, to assess efficacy (in terms of response rate and CR) and toxicity of bendamustine, bortezomib and prednisone (BVP) in 60 patients newly diagnosed MM. Patients in the absence of disease progression or unacceptable toxicity receive up to 9 cycles of BVP. The patients eligible for autologous transplant receive four cycles of BVP, hematopoietic stem cell collection and administration of two cycles BVP over followed by autologous transplant.

In addition to the overall response rates, will also be analyzed time to progression (TTP), progression-free survival (PFS) and overall survival.

Read more

Finally, the results will be compared with BVP with those obtained in 120 patients included in our protocol VMP GEM10MAS65.

Patients will be evaluated at scheduled visits up to 3 periods of study:

pretreatment, treatment and monitoring.

Read the detailed description

Patients included in the study will receive a 6 week cycle consisting of Bendamustine administered IV at doses of 90 mg/m2 on days 1 and 4 of the first cycle and days 1 and 8 in subsequent cycles in combination with Bortezomib as a bolus dose of 1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29 and 32, and oral prednisone at doses of 60 mg/m2, during the first four days of each cycle.

Then, patients will receive eight additional cycles of 5-week . The same pattern consisting of bendamustine and prednisone but bortezomib is administered as an intravenous bolus dose of 1.3 mg/m2 on days 1, 8, 15 and 22.

Being tested
Bendamustine, Velcade, Prednisone
Medical subject headings
Multiple Myeloma

What participants receive

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

What is being measured

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

  1. Efficacy in terms of response rate and complete response rate (CR and near CR)

    Measured: 1 year

Secondary outcomes (4)

  1. Safety in terms of toxicity

    Measured: 1 year

  2. Time to progresion

    Measured: 3 years

  3. Progresion free survival

    Measured: 2 years

  4. Global survival

    Measured: 3 years

Timeline

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

  1. First posted20 Jun 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJun 2014
  4. Study completionDec 2015

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01376401
Sponsor's protocol ID
BenVelPres
Status last verified
May 2016
First submitted
15 Jun 2011
Last updated
17 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Mateos MV, Oriol A, Rosinol L, de Arriba F, Puig N, Martin J, Martinez-Lopez J, Echeveste MA, Sarra J, Ocio E, Ramirez G, Martinez R, Palomera L, Payer A, Iglesias R, de la Rubia J, Alegre A, Chinea AI, Blade J, Lahuerta JJ, San Miguel JF. Bendamustine, bortezomib and prednisone for the treatment of patients with newly diagnosed multiple myeloma: results of a prospective phase 2 Spanish/PETHEMA trial. Haematologica. 2015 Aug;100(8):1096-102. doi: 10.3324/haematol.2015.124818. Epub 2015 Apr 24.

    PubMed 25911554

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine, Velcade and Prednisone in people with Multiple Myeloma, run by PETHEMA Foundation at 14 sites in Spain.

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 14 inclusion and 14 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Spain. 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?

Efficacy in terms of response rate and complete response rate (CR and near CR) (time frame: 1 year). 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 NCT01376401, 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 17 May 2016.

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