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.
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC Identifier:
First received: January 22, 2010
Last updated: July 1, 2015
Last verified: July 2015
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:
  • Complete response (CR) rate as measure of efficacy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Efficacy of the Bendamustine-Bortezomib-Dexamethosane (BBD) combination will be assessed using the International Myeloma Working group Uniform Response Criteria. Defined as an observed CR rate of 25%.

  • Number of treatment-emergent toxicities as a measure of safety and tolerability. [ Time Frame: every cycle (4 weeks) until disease progression or intolerable toxicity occurs, up to 34 weeks ] [ Designated as safety issue: Yes ]
    Assessed using NCI CTCAE v4.0

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: every 4 weeks, projected 24 months ] [ Designated as safety issue: No ]
    Defined as the date of first protocol treatment to date of documented tumor progression or date of death.

  • Overall Survival [ Time Frame: Every 4 weeks until disease progression or death, projected 24 months ] [ Designated as safety issue: No ]
    Defined as the interval from the first study treatment until the date of death

  • Overall Response Rate [ Time Frame: every 4 weeks until treatment discontinuation, projected 24 months ] [ Designated as safety issue: No ]
    Defined as the proportion of patients with observed complete response (CR) or partial response (PR).

Estimated Enrollment: 42
Study Start Date: May 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (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 Name: Treanda
Drug: Bortezomib
1.3 mg/m2 IV Days 1, 4, 8, 11; repeat cycles every 28-days
Other Name: Velcade
Drug: Dexamethasone
40 mg PO Days 1, 2, 3, 4; repeat cycles every 28-days


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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 identifier: NCT01056276

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
National Capital Clinical Research Consortium
Bethesda, Maryland, United States, 20817
Center for Cancer and Blood Disorders
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.
Study Chair: Jesus Berdeja, M.D. SCRI Development Innovations, LLC
  More Information

Responsible Party: SCRI Development Innovations, LLC Identifier: NCT01056276     History of Changes
Other Study ID Numbers: SCRI MM 23 
Study First Received: January 22, 2010
Last Updated: July 1, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by SCRI Development Innovations, LLC:
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases
BB 1101
Bendamustine Hydrochloride
Dexamethasone 21-phosphate
Dexamethasone acetate
Alkylating Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Autonomic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids processed this record on May 23, 2016