Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy of BBD in the initial treatment of multiple myeloma as measured by the complete response rate.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Jesus Berdeja, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Institutional Review Board

Study ID:

SCRI MM 23

NCT ID:

NCT01056276

Start Date:

May 2010

Completion Date:

December 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Bendamustine
  • Bortezomib
  • Dexamethasone
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Florida Cancer SpecialistsFort Myers, Florida  33901
South Carolina Oncology AssociatesColumbia, South Carolina  29201
Oncology Hematology Care Inc.Cincinnati, Ohio  45242
Peninsula Cancer InstituteNewport News, Virginia  23601
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Tennessee OncologyNashville, Tennessee  37203
Hematology Oncology Clinic, LLPBaton Rouge, Louisiana  70809
National Capital Clinical Research ConsortiumBethesda, Maryland  20817
Chattanooga Oncology Hematology AssociatesChattanooga, Tennessee  37404
Leading Edge Research, PADallas, Texas  75230
Los Robles Hospital and Medical CenterThousand Oaks, California  91360