Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Phase II, Open Label Study Evaluating an Alternative Schedule of Velcade/Dexamethasone Plus Doxil in the Treatment of Multiple Myeloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00366106
• Other study ID #: ACORN ALJBMM0502
• Status: Terminated
• Phase: Phase 2
• First received: August 16, 2006
• Last updated: April 4, 2012
• Start date: July 2006
• Est. completion date: March 2011

Study information

• Verified date: April 2012
• Source: Accelerated Community Oncology Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The current study is being conducted to evaluate the possibility that a different schedule of bortezomib, doxorubicin HCl liposome, and dexamethasone might decrease the incidence of peripheral neuropathy yet maintain similar efficacy and allow maintenance of bortezomib dosing for a longer period.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is at least 18 years of age.

• Patient has confirmed diagnosis of relapsed/refractory multiple myeloma with measurable disease by serum or urine. Measurable disease defined as monoclonal protein of = 1g/dl on serum protein electrophoresis (SPEP) or > 200 mg urine M protein/ 24 hours

• Patient has received at least 1 prior treatment regimen. (Prior treatment with bortezomib is allowed.)

• Patient has ECOG = 2

• Patient provides voluntary written informed consent before performance of any study-relates procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

• Patients who have received prior high dose chemotherapy with stem cell support are eligible for this study.

• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.

• Male subject agrees to use an acceptable method for contraception for the duration of the study.

Exclusion Criteria:

• Patient has a platelet count of < 50, 000 cells/mm³, within 14 days before enrollment.

• Patient has an absolute neutrophil count (ANC) = 750/mm³ within 14 days before enrollment.

• Patient has a calculated or measured creatinine clearance of < 20 mL/min within 14 days before enrollment and/or serum creatinine = 2.5 mg/dl.

• Patient has hemoglobin < 7.5 g/dl.

• Patient has = Grade 2 peripheral neuropathy within 14 days before enrollment.

• Myocardial infarction within 6 months prior to enrollment or has (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant.

• Patient has received a total cumulative dosage of anthracyclines exceeding 550 mg/m2.

• Patient has hypersensitivity to boron or mannitol.

• Patient has history of hypersensitivity reactions to a conventional formulation of doxorubicin HCl or the components of DOXIL.

• Patient has clinically significant coexisting illness unrelated to myeloma.

• Patient has uncontrolled diabetes.

• Patient has plasma cell leukemia.

• Patient has serum bilirubin > 1.5 x upper normal limit, alanine aminotransaminase (ALT), aspartate aminotransferase (AST) > 2.5 x upper normal limit (ULN), or alkaline phosphatase > 2.5 x ULN.

• Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG)pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.

• Patient has received other investigational drugs within 14 days before enrollment.

• Patient has serious medical or psychiatric illness likely to interfere with participation in this clinical study.

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• bortezomib
Patients will be treated with bortezomib at 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days (cycle).
• dexamethasone
Dexamethasone tablets will be given at 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days (cycle).
• doxorubicin HCl liposome
Patients will receive intravenous doxorubicin HCl liposome injection given at 30 mg/m^2 on Day 4 every 28 days (cycle).

Locations

Country	Name	City	State
United States	Northeast Georgia Cancer Care	Athens	Georgia
United States	Augusta Oncology Associates, PC	Augusta	Georgia
United States	Hematology Oncology Centers of the Northern Rockies, PC	Billings	Montana
United States	Tri-County Hematology and Oncology Associates	Canton	Ohio
United States	Cancer Specialists of Tidewater, Ltd.	Chesapeake	Virginia
United States	Oncology-Hematology Associates, P.A.	Clinton	Maryland
United States	North Idaho Cancer Center	Coeur d'Alene	Idaho
United States	Mid Ohio Oncology/Hematology, Inc.	Columbus	Ohio
United States	Wilshire Oncology Medical Group, Inc.	La Verne	California
United States	Arena Oncology Associates	Lake Success	New York
United States	Lancaster Cancer Center, Ltd.	Lancaster	Pennsylvania
United States	Northwest Georgia Oncology Centers, PC	Marietta	Georgia
United States	The West Clinic	Memphis	Tennessee
United States	Advanced Medical Specialties	Miami	Florida
United States	Medical Oncology & Hematology	Waterbury	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Accelerated Community Oncology Research Network	Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-emergent Peripheral Neuropathy		Every 4 weeks from start of treatment until end of treatment	Yes
Secondary	Time to Progression (TTP)		TTP was measured from day 1 of treatment until time of progression, assessed up to 40 months	No
Secondary	Number of Participants With Treatment Response	Complete Response (CR), Partial Response (PR), and Minor Response (MR) each required stable bone disease and normal calcium levels. CR also required 100% serum protein electrophoresis (SPEP) reduction, negative immunofixation (IF), 100% urine protein electrophoresis (UPEP)reduction, and <5% plasma cells in bone marrow. PR also required >=50% SPEP reduction, >=90% UPEP reduction, and >=50% reduction in plasma cells in bone marrow. MR also required >=25% SPEP reduction, >=50% UPEP reduction, and > 25% reduction in plasma cells.	Every 8 weeks from start of treatment until end of treatment	No
Secondary	Relative Dose Intensity of Bortezomib	Relative dose intensity is defined as actual dose/scheduled dose. Bortezomib is administered on Days 1, 4, 15, and 18 every 28 days.	Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days)	No