Phase II Trial Designed to Determine Efficacy and Safety of Bendamustine+Dexamethasone+Thalidomide in R/R MM

NCT01526694 | Completed Phase 2

• 1 other identifier: BDT-01-2011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 19

Brief Summary

This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a combination chemotherapy consisting of Bendamustine + Dexamethasone + Thalidomide in patients with multiple myeloma (MM) after treatment with lenalidomide and bortezomib or which are ineligible to one of these drugs.

Conditions

Multiple Myeloma

Keywords

relapsed or refractory multiple myeloma

Outcome Measures

Primary Outcomes (2)

• Response rate

  The proportion of patient with a Complete Response (CR) or Very Good Partial Response or partial response

  18 months

• Incidence of haematological toxicity of BDT

  The incidence of haematological toxicities is the proportion of patients with haematological toxicity

  18 months

Secondary Outcomes (3)

• Time to treatment Failure (TTF)

  18 months

• Survival (OS)

  18 months

• Disease Free Survival (DFS)

  18 months

Study Arms (1)

treatment with BDT

EXPERIMENTAL

Bendamustine + Dexamethasone + Thalidomide in patients with multiple myeloma (MM) patients after treatment with lenalidomide and bortezomib or which are ineligible to one of these drugs.

Drug: Bendamustine; Drug: Thalidomide; Drug: Dexamethasone

Interventions

Bendamustine DRUG

Bifunctional alkylating agent consisting of a purine and amino acid antagonist (a benzimidazole ring) and an alkylating nitrogen mustard moiety.

Also known as: Ribomustin

treatment with BDT

Thalidomide DRUG

Thalidomide can directly inhibit the growth and survival of myeloma cells, by oxidative damage to DNA mediated by free radicals. The drug can induce apoptosis even in drug resistant myeloma cells. Thalidomide modulates cell adhesion molecule expression, so it may interfere with the mutually stimulatory interactions between myeloma cells and the bone marrow microenvironment.

treatment with BDT

Dexamethasone DRUG

It's a corticosteroid.

treatment with BDT

Eligibility Criteria

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

You may qualify if:

• Understand and voluntarily sign an informed consent form.
• Age 18 years at the time of signing the informed consent form.
• Life expectancy of at least 3 months
• Able to adhere to the study visit schedule and other protocol requirements
• Relapsed or refractory active MM (according to the International Myeloma Working Group guidelines) after treatments containing bortezomib and lenalidomide or ineligible (intolerance or toxicity) to one of these drugs with detectable myeloma protein in blood or urine.
• Disease free of prior malignancies for at least 5 years.
• All previous multiple myeloma treatments, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, except corticosteroids therapy.
• ECOG performance status \<2 at study entry, unless it is due to MM.
• At least the following laboratory findings at the day of treatment start:
• Platelet count ≥ 75 x 10\^9/L without transfusional support within 7 days.
• Neutrophil count \> 1.5 x 10\^9/L without G-CSF.
• Corrected calcium ≤ 14 mg/dL (3.5 mmol/L).
• AST: ≤ 2.5 times the normal upper limit.
• ALT: ≤ 2.5 times the normal upper limit.
• Total bilirubin: ≤ 1.5 times the normal upper limit.

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.
• Pregnant or breast feeding females.
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Patients with contraindications for treatment with bendamustine, dexamethasone and thalidomide.
• Uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before study entry, New York Heart Association Class III or IV heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (≥ Lown 3).
• Use of any other experimental drug or therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide or purine analogues
• Concurrent use of other anti-cancer agents or treatments other stated in this treatment plan.
• Peripheral neuropathy grade ≥2 according to WHO
• Known positive for HIV or infectious hepatitis, type A, B or C.
• Major surgery less than 30 days before start of treatment

Sponsors & Collaborators

• Azienda Ospedaliera di Bolzano: lead
• Mundipharma Pte Ltd.: collaborator

Study Sites (19)

Division of Hematology and CBMT

Bolzano, BZ, 39100, Italy

Location

Presidio Ospedaliero di Camposampiero

Camposampiero, Padova, 35012, Italy

Location

Ospedale S. Martino

Belluno, 32100, Italy

Location

Ospedale di Castelfranco Veneto

Castelfranco Veneto, 31033, Italy

Location

Ospedale Civile di Dolo

Dolo, 30031, Italy

Location

AULSS 2 Feltre

Feltre, 32032, Italy

Location

Azienda Ospedaliera Universitaria G. Martino

Messina, 98125, Italy

Location

Ospedale dell'Angelo di Mestre

Mestre, 30170, Italy

Location

A.O di Padova Ematologia e Immunologia Clinica

Padua, 35127, Italy

Location

A.O di Padova Ematologia

Padua, 35127, Italy

Location

AULLS 18 di Rovigo

Rovigo, 45100, Italy

Location

Ospedale di Trento - P.O. S. Chiara

Trento, 38100, Italy

Location

Ospedale Ca Foncello

Treviso, 31100, Italy

Location

A.O.U Ospedali Riuniti di Trieste Medicina II

Trieste, 34142, Italy

Location

A.O.U Ospedali Riuniti di Trieste

Trieste, 34142, Italy

Location

A.O.U S. Maria della Misericordia

Udine, 33100, Italy

Location

Ospedale Policlinico G.B Rossi (Borgo Roma) Ematologia

Verona, 37134, Italy

Location

Ospedale Policlinico G.B Rossi (Borgo Roma) Medicina II

Verona, 37134, Italy

Location

AULSS 6 Vicenza

Vicenza, 36100, Italy

Location

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

Bendamustine Hydrochloride; Thalidomide; Dexamethasone

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Isoindoles; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Michael Mian, MD

  Azienda Ospedaliera di Bolzano

  PRINCIPAL INVESTIGATOR

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: MD

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: February 6, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: April 8, 2017
• Last Updated: July 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (19)