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A Phase I/II Trial of Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed or Refractory Multiple Myeloma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

A Phase I/II Trial of Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed or Refractory Multiple Myeloma


Phase I component Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11 Doxorubicin 30 mg/m2
IV over 1 hour, Day 4 Bendamustine escalating cohorts IV over 1 hour, Days 1 and 4 1 Cycle =
28 days

Phase II component Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11 Doxorubicin 30 mg/m2
IV over 1 hour, Day 4 Bendamustine at MTD IV over 1 hour, Days 1 and 4 Filgrastim (if
defined in MTD) 5 µg/kg/day SC, Starting day 6 until neutrophil recovery to ANC >1000

1 Cycle = 28 days; Patients will continue treatment for a total of up to 8 cycles.

ECOG Performance Status: 0-2

Hematopoietic:

- Absolute neutrophil count (ANC) ≥ 1.2 x K/mm3

- Platelets ≥ 75 x K/mm3

Hepatic:

- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

- AST ≤ 2.5 x ULN

- ALT ≤ 2.5 x ULN

Renal:

- Serum creatinine < 3.0 mg/dL

Cardiovascular:

- LVEF >45% corrected by MUGA scan or echocardiogram.

- No unstable angina pectoris or recent myocardial infarction (within 6 months)


Inclusion Criteria:



- A histologically established diagnosis of multiple myeloma with evidence of relapse
or refractory disease.

- Must have a detectable serum or urine M-Protein by protein electrophoresis that is at
least 500 mg/dL (serum) or 1 gm/24 hours (urine), respectively, or serum free light
chain level >100 mg/l for the involved free light chain.

- Must have received at least one (1) prior line of systemic treatment that has
included either lenalidomide or thalidomide.

- Must be willing to provide correlative blood samples.

Exclusion Criteria:

- Must not have received an excessive cumulative dose of anthracycline

- No ≥ grade 2 peripheral neuropathy.

- No cytotoxic chemotherapy within 30 days prior to registration for protocol therapy.

- No autologous stem cell transplant within 6 months prior to registration for protocol
therapy

- No prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis)
within 30 days prior to registration for protocol therapy. See Study Procedures
Manual to calculate percent of prior radiation.

- No current corticosteroid therapy in doses greater than 10 mg daily of prednisone (or
equivalent) if given for management of co-morbid conditions.

- No known central nervous system involvement by myeloma.

- No poorly controlled intercurrent illness including, but not limited to, ongoing or
active infection, poorly controlled diabetes, symptomatic congestive heart failure,
cardiac arrhythmia, or psychiatric illness/social climate that in the opinion of the
investigator would limit compliance with study requirements.

- No patients known to be positive for HIV, or active Hepatitis A, B, or C.

- No major surgery within 30 days prior to registration for protocol therapy.
Placement of a venous access device within 30 days prior to registration for protocol
therapy is allowed.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Assessing Patient Response to Bendamustine - Phase I by assessing patient adverse events

Outcome Description:

Determine the maximum tolerated dose of bendamustine in association with bortezomib and pegylated liposomal doxorubicin in patients with relapsed or refractory Multiple Myeloma.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Sherif Farag, M.B., B.S.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group

Authority:

United States: Institutional Review Board

Study ID:

MM08-141

NCT ID:

NCT01177683

Start Date:

July 2010

Completion Date:

December 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Cancer Care Center Of Southern IndianaBloomington, Indiana  47403
Community Regional Cancer CenterIndianapolis, Indiana  46256
IU Health Arnett Cancer CenterLafayette, Indiana  47904
IU Health Central Indiana Cancer CentersIndianapolis, Indiana  46219
Metro Health Cancer CareWyoming, Michigan  49519
IU Health Goshen HospitalGoshen, Indiana  46527
Floyd Memorial Cancer Center of IndianaNew Albany, Indiana  47150
University Hospitals Seidman Cancer CenterCleveland, Ohio  44106