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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01056276
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : March 28, 2017
Last Update Posted : May 3, 2017
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Brief Summary:
In this study, 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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: Bendamustine Drug: Bortezomib Drug: Dexamethasone Phase 2

Detailed Description:
The purpose of this study is to assess the efficacy, tolerability, and toxicity of bendamustine, bortezomib, and dexamethasone (BBD) as first-line treatment of multiple myeloma (MM) patients who are transplant ineligible or who are not candidates for high dose chemotherapy. Eligible patients will receive protocol treatment for up to 34 weeks plus the screening period (up to 2 weeks). Response assessments will occur every 4 weeks and confirmed using the International Myeloma Working Group Uniform Response Criteria. Patients having an objective response or stable disease will continue to maintenance therapy until disease progression or intolerable toxicity.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2010
Actual Primary Completion Date : August 2015
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: Treatment
Bendamustine, Bortezomib,and Dexamethasone for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by IMWG criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone until disease progression or intolerable toxicity.
Drug: Bendamustine
Treatment: 80 mg/m2 via intravenous (IV) Days 1 and 2; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response.
Other Name: Treanda

Drug: Bortezomib

1.3 mg/m2 IV Days 1, 8, 15; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response.

Maintenance: 1.3 mg/m2 IV or SQ Days 1, 15

Other Name: Velcade

Drug: Dexamethasone
20 mg orally (PO) Days 1, 2, 8, 9, 15, 16 every 28-days for 8 cycles or 2 cycles beyond confirmed complete response, Maintenance: 20 mg PO Days 1, 15

Primary Outcome Measures :
  1. Complete Response Rate [ Time Frame: every 8 weeks for approximately 48 months ]
    Defined as the percent of patients having a complete response (CR) to treatment, assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. CR=disappearance of soft tissue plasmacytomas and 5% or less plasma cells in bone marrow.

  2. Number of Patients Who Experienced Serious and Non-serious Adverse Events [ Time Frame: approximately 36 weeks ]
    All serious adverse events (SAEs) and non-serious adverse events (AEs) were assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0, and were collected from start of study treatment until 30 days after last dose of study medication. Refer to the Adverse Event module for specific terms.

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: every 8 weeks for up to 48 months ]
    Defined as the interval of time (in months) that patient are alive from date of first protocol treatment to date of documented tumor progression or date of death from any cause. Progressive disease, assessed according to International Myeloma Working Group Uniform Response Criteria, is defined as at least a 25% increase from the nadir in any one of the following criteria: serum M-protein, urine M-protein, or bone marrow plasma cell percentage of 10% or greater.

  2. Overall Survival [ Time Frame: every 4 weeks until progressive disease then every 12 weeks, projected 48 months ]
    Defined as the interval of time, in months, from first study treatment until the earlier of the date of death or date last known alive.

  3. Overall Response Rate [ Time Frame: every 4 weeks for approximately 2 years ]
    The number of patients with observed complete or partial response (CR or PR) assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. PR=50% or greater reduction from baseline in serum M-protein and 90% or greater reduction from baseline in 24-hour urinary M-protein.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01056276

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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.
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Study Chair: Jesus Berdeja, M.D. SCRI Development Innovations, LLC
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Responsible Party: SCRI Development Innovations, LLC Identifier: NCT01056276    
Other Study ID Numbers: SCRI MM 23
First Posted: January 26, 2010    Key Record Dates
Results First Posted: March 28, 2017
Last Update Posted: May 3, 2017
Last Verified: March 2017
Keywords provided by SCRI Development Innovations, LLC:
Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bendamustine Hydrochloride
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents