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

NCT02237261 | Completed Phase 2 DMC

• 2 other identifiers: BPV2013-005485-19
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Multiple Myeloma

Keywords

Newly diagnosed symptomatic multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) of BPV

  ORR is defined as PR or better

  2 years

Secondary Outcomes (10)

• Number and percentage of patients achieving a complete response

  2 years

• Progression-free survival (PFS)

  2 years

• Overall survival (OS)

  2 years

• Time-to-progression (TTP)

  2 years

• Disease-free survival (DFS)

  2 years

Study Arms (1)

Bendamustine, Bortezomib, Prednisone

EXPERIMENTAL

Induction: 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

Drug: Bendamustine, Bortezomib, Prednisone

Interventions

Bendamustine, Bortezomib, Prednisone DRUG

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

Also known as: Velcade (Bortezomib), Levact (Bendamustine)

Bendamustine, Bortezomib, Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• WHO performance status 0-3 (WHO=3 is allowed only when related to MM and not to co-morbid conditions) (see appendix III)
• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• German Cancer Research Center: collaborator
• Janssen-Cilag International NV: collaborator
• Mundipharma Research GmbH & Co KG: collaborator
• inVentiv Health Clinical: collaborator

Study Sites (15)

Mannheimer Onkologie Praxis

Mannheim, Ba-Wü, 68161, Germany

Location

Onkologische Schwerpunktpraxis

Heidelberg, Baden-Wurttemberg, 69115, Germany

Location

Medizinische Klinik V, Universitätsklinikum Heidelberg, Sektion Multiples Myelom

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Hämatologisch-Onkologische gemeinschaftspraxis

Augsburg, Bavaria, 86150, Germany

Location

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

Würzburg, Bavaria, 97080, Germany

Location

Onkologische Schwerpunktpraxis Dr. G. Kojouharoff

Darmstadt, Hesse, 64295, Germany

Location

Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanienkrankenhaus

Frankfurt am Main, Hesse, 60389, Germany

Location

Agaplesion Markus Krankenhaus gGmbH, Medizinisches Versorgungszentrum

Frankfurt am Main, Hesse, 60431, Germany

Location

Onkologische Gemeinschaftspraxis

Cologne, North Rhine-Westphalia, 50677, Germany

Location

Onkologisches Ambulanzzentrum Hannover am Diakoniekrankenhaus Henriettenstift gGmbH

Hannover, North Rhine-Westphalia, 30171, Germany

Location

Klinikum Idar-Oberstein GmbH, Innere Medizin I

Idar-Oberstein, Rh-Pfalz, 55743, Germany

Location

Onkologische Schwerpunktpraxis Speyer

Speyer, Rhineland-Palatinate, 67346, Germany

Location

Städtische Klinikum Dessau

Dessau, Saxony-Anhalt, 06847, Germany

Location

Klinikum Aschaffenburg, Med. Klinik II

Aschaffenburg, 63739, Germany

Location

Onkologische Praxis Oldenburg/Delmenhorst

Oldenburg, 26121, Germany

Location

Related Publications (1)

• 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.

  PMID: 32155662 RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bendamustine Hydrochloride; Bortezomib; Prednisone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Wolfgang Knauf, MD

  Hematology/Oncology,Bethanien hospital, Im Pruefling 17-19, 60389 Frankfurt/M., Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marc S. Raab MD, Medical Hospital V (Hematology, Oncology, Rheumatology), Section multiple myeloma

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: September 11, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

DE (15)