Phase II Study for the Evaluation of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Millennium Pharmaceuticals, Inc.
Cephalon
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01056276
First received: January 22, 2010
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

In this study, the investigators will evaluate the activity of bendamustine, bortezomib and dexamethasone (BBD). This regimen combines 3 agents with high activity in multiple myeloma, with different mechanisms of action and non-overlapping toxicities.


Condition Intervention Phase
Multiple Myeloma
Drug: Bendamustine
Drug: Bortezomib
Drug: Dexamethasone
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 Study for the Evaluation of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • To evaluate the efficacy of BBD in the initial treatment of multiple myeloma as measured by the complete response rate. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To assess the tolerability and toxicity of BBD in this patient population. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate, progression-free and overall survival. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: May 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Systemic Treatment
All patients will receive 2 cycles (8 weeks) of Bendamustine, Bortezomib,and Dexamethasone.
Drug: Bendamustine
80 mg/m2 IV Days 1 and 4; repeat cycles every 28-days
Other Names:
  • Bendamustine
  • Treanda
Drug: Bortezomib
1.3 mg/m2 IV Days 1, 4, 8, 11; repeat cycles every 28-days
Other Names:
  • Bortezomib
  • Velcade
Drug: Dexamethasone
40 mg PO Days 1, 2, 3, 4; repeat cycles every 28-days
Other Name: Dexamethasone

  Eligibility

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

Inclusion Criteria:

  1. Patients must meet the Durie and Salmon criteria for initial diagnosis of multiple myeloma.
  2. Previously histologically confirmed, multiple myeloma with indication for therapy including one of the following:

    • Hemoglobin <10 g/dl or 2 g/dl below normal
    • Serum calcium >11.5 mg/dl
    • Creatinine >2 mg/dl
    • Lytic bone lesions or severe osteopenia
    • Extramedullary plasmacytomas
  3. Patients should not be considered candidates for high dose therapy/autologous stem cell transplantation due to coexistent medical conditions, advanced age, poor performance status, refusal of high dose chemotherapy, or other reasons as judged by the patient and/or physician.
  4. ECOG Performance Status 0-2.
  5. WBC ≥3000/mL; ANC ≥1000/mL; platelets ≥50,000/mL (patients with platelets ≥30,000/mL are eligible if thrombocytopenia is felt to be due to extensive bone marrow involvement with myeloma).
  6. Patients with adequate organ function as measured by:

    Renal: Serum creatinine <2.0 mg/dL or a calculated or measured creatinine clearance of >30 mL/minute.

    Hepatic: Total bilirubin < 1.5 x ULN and ALT and AST <2.5 x the ULN (<5 x ULN for patients with liver involvement).

  7. Patients must have measurable or evaluable disease. In patients with disease limited to bone and bone marrow, serial paraprotein measurements are acceptable for evaluable disease.
  8. Patients must be accessible for treatment and follow-up procedures.
  9. Male or female patients 18 years of age or older.
  10. Patients must provide written informed consent prior to receiving protocol therapy.
  11. Women of childbearing potential must agree to use a medically acceptable method of birth control(e.g., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 12 months after their last dose of rituximab. Men must use an acceptable form/method of contraception for the duration of treatment and for 3 months after the end of treatment.
  12. Patients must be able to understand the nature of this study and give written informed consent.

Exclusion Criteria:

  1. Previous therapy for multiple myeloma with the exception of an initial 4-day course of pulsed dexamethasone.
  2. Patients with ≥NCI CTCAE v4.0 grade 2 peripheral neuropathy ≤14 days prior to study enrollment.
  3. Treatment with investigational agent(s) ≤14 days prior to study enrollment.
  4. Active infection or infection requiring intravenous antibiotic treatment at the time of accrual.
  5. Known to be HIV positive (HIV test is not required for participation in the trial).
  6. Patients with class III/IV cardiac problems as defined by the New York Heart Association (NYHA)criteria:

    • History of uncontrolled or symptomatic angina
    • History of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation
    • Myocardial infarction < 6 months from study entry
    • Uncontrolled or symptomatic congestive heart failure
    • Ejection fraction below the institutional normal limit
    • Any other cardiac condition that, in the opinion of the treatment physician, would make this protocol unreasonably hazardous for the patient
    • Uncontrolled hypertension (systolic blood pressure [BP] >180 or diastolic BP >100mm Hg)or uncontrolled cardiac arrhythmias.
    • Prior to study entry, any ECG abnormality at Screening must be documented by the investigator as not medically relevant.
  7. Other serious medical conditions or psychiatric illness that would potentially interfere with patient participation in this trial.
  8. A second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix,unless the tumor was treated with curative intent at least 2 years previously or low-risk prostate cancer after curative therapy.
  9. Known hypersensitivity to bortezomib, boron, or mannitol.
  10. Female patient is pregnant or lactating. Confirmation that female patients of childbearing potential are not pregnant must be established by a negative serum pregnancy test ≤7 days prior to 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: NCT01056276

Locations
United States, California
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States, 91360
United States, Florida
Florida Cancer Specialists
Ft. Myers, Florida, United States, 33916
United States, Louisiana
Hematology Oncology Clinic, LLP
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
National Capital Clinical Research Consortium
Bethesda, Maryland, United States, 20817
United States, Michigan
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
United States, Ohio
Oncology Hematology Care Inc.
Cincinnati, Ohio, United States, 45242
United States, South Carolina
South Carolina Oncology Associates
Columbia, South Carolina, United States, 29210
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology
Nashville, Tennessee, United States, 37203
United States, Texas
Leading Edge Research, PA
Arlington, Texas, United States, 75213
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
United States, Virginia
Peninsula Cancer Institute
Newport News, Virginia, United States, 23601
Sponsors and Collaborators
SCRI Development Innovations, LLC
Millennium Pharmaceuticals, Inc.
Cephalon
Investigators
Study Chair: Jesus Berdeja, M.D. SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01056276     History of Changes
Other Study ID Numbers: SCRI MM 23
Study First Received: January 22, 2010
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by SCRI Development Innovations, LLC:
Multiple Myeloma
Bendamustine
Bortezomib
Dexamethasone

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
Bendamustine
Bortezomib
Nitrogen Mustard Compounds
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 20, 2014