Clinical trial NCT00366106: Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma
Official title: A Phase II, Open Label Study Evaluating an Alternative Schedule of Velcade/Dexamethasone Plus Doxil in the Treatment of Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Lead sponsor: Accelerated Community Oncology Research Network
Sponsor class: OTHER
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2006-08-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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performance of any study-relates procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.

Primary outcomes:
measure: Incidence of Treatment-emergent Peripheral Neuropathy
timeFrame: Every 4 weeks from start of treatment until end of treatment
Secondary outcomes:
measure: Time to Progression (TTP)
timeFrame: TTP was measured from day 1 of treatment until time of progression, assessed up to 40 months
measure: Number of Participants With Treatment Response
timeFrame: Every 8 weeks from start of treatment until end of treatment
measure: Relative Dose Intensity of Bortezomib
timeFrame: Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days)
Other outcomes:
Locations:
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group, Inc.
state: California
city: Waterbury
country: United States
facility: Medical Oncology & Hematology
state: Connecticut
city: Miami
country: United States
facility: Advanced Medical Specialties
state: Florida
city: Athens
country: United States
facility: Northeast Georgia Cancer Care
state: Georgia
city: Augusta
country: United States
facility: Augusta Oncology Associates, PC
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, PC
state: Georgia
city: Coeur d'Alene
country: United States
facility: North Idaho Cancer Center
state: Idaho
city: Clinton
country: United States
facility: Oncology-Hematology Associates, P.A.
state: Maryland
city: Billings
country: United States
facility: Hematology Oncology Centers of the Northern Rockies, PC
state: Montana
city: Lake Success
country: United States
facility: Arena Oncology Associates
state: New York
city: Canton
country: United States
facility: Tri-County Hematology and Oncology Associates
state: Ohio
city: Columbus
country: United States
facility: Mid Ohio Oncology/Hematology, Inc.
state: Ohio
city: Lancaster
country: United States
facility: Lancaster Cancer Center, Ltd.
state: Pennsylvania
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Chesapeake
country: United States
facility: Cancer Specialists of Tidewater, Ltd.
state: Virginia
Study officials:
affiliation: Accelerared Community Oncology Research Network, Inc.
name: Johnetta Blakely, MD
role: PRINCIPAL_INVESTIGATOR
References: