Multicenter Clinical Trial to Investigate the Efficacy and Safety of Bendamustine, Dexamethasone and Thalidomide in Relapsed or Refractory Multiple Myeloma Patients After Treatment With Lenalidomide and Bortezomib or Which Are Ineligible to One of These Drugs

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Azienda Ospedaliera di Bolzano.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Mundipharma Pte Ltd.
Information provided by (Responsible Party):
Michael Mian, Azienda Ospedaliera di Bolzano
ClinicalTrials.gov Identifier:
NCT01526694
First received: January 27, 2012
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

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) patients after treatment with lenalidomide and bortezomib or which are ineligible to one of these drugs.


Condition Intervention Phase
Multiple Myeloma
Drug: Bendamustine + Dexamethasone + Thalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Multicenter Clinical Trial to Investigate the Efficacy and Safety of Bendamustine, Dexamethasone and Thalidomide in Relapsed or Refractory Multiple Myeloma Patients After Treatment With Lenalidomide and Bortezomib or Which Are Ineligible to One of These Drugs

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera di Bolzano:

Primary Outcome Measures:
  • assessment of response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To evaluate the efficacy of BDT in relapsed or refractory multiple myeloma as measured by the rate of responses (blood and urine tests, X-ray, BMA and BMB, Karnofsky PS)

  • safety assessment [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    To assess the tolerability and toxicity in terms of number of participants with Adverse Events (laboratory tests, phyisical examination and ECGs).


Secondary Outcome Measures:
  • SURVIVAL [ Time Frame: 18 MONTHS ] [ Designated as safety issue: No ]
    Time to treatment failure, overall survival and disease free survival.


Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment with BDT
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 + Dexamethasone + Thalidomide
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • Measured or calculated creatinine clearance of ≥ 20 mL/minute
  • Women of child bearing potential and male patients whose partner is a woman of child bearing potential must be prepared to use two effective methods of contraception both before and during protocol treatment, or commit to absolute and continuous abstinence.The pregnancy test must be negative 14-28 days and 72 hours before treatment start. Only in case of hysterectomy or presence of menopause for at least 24 consecutive months pregnancy tests as well as contraception are not necessary. Men must not father a child for up to 6 months following cessation of treatment and must use condoms.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526694

Contacts
Contact: Michael Mian, MD +39 0471 908807 michael.mian@asbz.it

Locations
Italy
Division of Hematology and CBMT Recruiting
Bolzano, BZ, Italy, 39100
Contact: Michael Mian, MD    +39 0471 908807    michael.mian@asbz.it   
Principal Investigator: Sergio Cortelazzo, MD         
Sub-Investigator: Michael Mian, MD         
Sub-Investigator: Norbert Pescosta, MD         
Sponsors and Collaborators
Azienda Ospedaliera di Bolzano
Mundipharma Pte Ltd.
Investigators
Principal Investigator: Sergio Cortelazzo, MD Azienda Ospedaliera di Bolzano
  More Information

No publications provided

Responsible Party: Michael Mian, co-investigator, Azienda Ospedaliera di Bolzano
ClinicalTrials.gov Identifier: NCT01526694     History of Changes
Other Study ID Numbers: BDT-01-2011
Study First Received: January 27, 2012
Last Updated: February 3, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera di Bolzano:
relapsed or refractory multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Bortezomib
Bendamustine
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014