Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT01177683|
Recruitment Status : Terminated (Lack of accrual)
First Posted : August 9, 2010
Last Update Posted : July 16, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Bendamustine Drug: Doxorubicin Drug: Bortezomib Drug: Filgrastim||Phase 1 Phase 2|
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
- Absolute neutrophil count (ANC) ≥ 1.2 x K/mm3
- Platelets ≥ 75 x K/mm3
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- AST ≤ 2.5 x ULN
- ALT ≤ 2.5 x ULN
- Serum creatinine < 3.0 mg/dL
- LVEF >45% corrected by MUGA scan or echocardiogram.
- No unstable angina pectoris or recent myocardial infarction (within 6 months)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed or Refractory Multiple Myeloma: Hoosier Cancer Research Network MM08-141|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Experimental: Arm 1
Bendamustine in combination with bortezomib and pegylated liposomal doxorubicin.
Phase I component:
Bendamustine escalating cohorts to determine MTD, IV over 1 hour, Days 1 and 4
Phase I and II components:
Pegylated liposomal doxorubicin, 30 mg/m2 IV over 1 hour, Day 4
Phase I and II components:
Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11
Phase II component:
Bendamustine at at MTD IV over 1 hour, Days 1 and 4
Phase II component:
Filgrastim (if defined in MTD) 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC >1000
- Assessing Patient Response to Bendamustine - Phase I by assessing patient adverse events [ Time Frame: 6 months ]Determine the maximum tolerated dose of bendamustine in association with bortezomib and pegylated liposomal doxorubicin in patients with relapsed or refractory Multiple Myeloma.
- Overall Response Rate of Treatment Regimen - Phase II by assessing patient response rates [ Time Frame: 8 months ]Assess the overall response rate (CR+PR) of bendamustine in association with bortezomib and pegylated liposomal doxorubicin in patients with relapsed or refractory Multiple Myeloma.
- Toxicity of Treatment Regimen - Phase I and II by assessing patient adverse events [ Time Frame: 6 months ]Describe the toxicity of the combination of bendamustine with bortezomib and pegylated liposomal doxorubicin.
- Evaluation of Survival - Phase II by assessing patient survival times [ Time Frame: 8 months ]Evaluate the time to progression, overall survival, progression free survival, and duration of response of Multiple Myeloma patients treated with bendamustine, bortezomib and pegylated liposomal doxorubicin.
- Bendamustine Pharmacokinetics - Phase II by evaluating patient samples [ Time Frame: 8 months ]Correlate bendamustine pharmacokinetics parameters (Cmax, t1/2, and AUC) at cycle 1 (and cycle 2) with patients' responses and correlate the DNA damage/repair at day 1 of cycle 1 and day 4 of cycle 2 with patients' responses.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01177683
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|IU Health Central Indiana Cancer Centers|
|Indianapolis, Indiana, United States, 46219|
|Community Regional Cancer Center|
|Indianapolis, Indiana, United States, 46256|
|IU Health Arnett Cancer Center|
|Lafayette, Indiana, United States, 47904|
|United States, Michigan|
|Metro Health Cancer Care|
|Wyoming, Michigan, United States, 49519|
|United States, Ohio|
|University Hospitals Seidman Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Study Chair:||Sherif Farag, M.B., B.S.||Hoosier Cancer Research Network|
|Responsible Party:||Sherif Farag, MB, BS, Sponsor-Investigator, Hoosier Cancer Research Network|
|Other Study ID Numbers:||
|First Posted:||August 9, 2010 Key Record Dates|
|Last Update Posted:||July 16, 2018|
|Last Verified:||July 2018|
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Topoisomerase II Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating