Bortezomib, Doxorubicin Hydrochloride Liposome, and Thalidomide as First-line Therapy in Treating Patients With Previously Untreated Stage I, II, or III Multiple Myeloma

NCT ID: NCT00523848

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2012-10-31

Brief Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving bortezomib together with doxorubicin hydrochloride liposome and thalidomide may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin hydrochloride liposome and thalidomide works as first-line therapy in treating patients with previously untreated multiple myeloma.

Detailed Description

OBJECTIVES:

Primary

• To determine the overall response rate (complete response and partial response) in patients previously untreated stage I, II, or III multiple myeloma.

Secondary

• To evaluate the complete response rate in patients treated with this regimen.
• To determine the time to disease progression from the start of this therapy in patients treated with this regimen.

OUTLINE: Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with residual disease who continue to show response after completion of 6 courses may receive 2 additional courses for a total of 8 courses.

After completion of study treatment, patients are followed every 3 months.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity

Group Type: EXPERIMENTAL

bortezomib

Intervention Type: DRUG

IV

pegylated liposomal doxorubicin hydrochloride

Intervention Type: DRUG

IV

thalidomide

Intervention Type: DRUG

Oral

Interventions

bortezomib

IV

Intervention Type: DRUG

pegylated liposomal doxorubicin hydrochloride

IV

Intervention Type: DRUG

thalidomide

Oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who have received 1 prior course of antimyeloma therapy may be enrolled at the investigator's discretion provided disease progression is not noted

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Platelet count ≥ 75,000 cells/mm^3 (< 75,000 cells/mm^3 secondary to extensive bone marrow disease allowed at the PI's discretion with appropriate transfusion support)
• ANC ≥ 1,000 cells/mm^3
• Hemoglobin ≥ 8.0 g/dL (< 8 g/dL secondary to extensive bone marrow disease allowed at the PI's discretion with appropriate transfusion support)
• Creatinine clearance > 20 mL/min
• AST and ALT ≤ 2 times upper limit of normal (ULN) OR ≤ 3 times ULN (in the presence of liver metastases)
• Alkaline phosphatase ≤ 2 times ULN OR ≤ 3 times ULN (in the presence of liver metastases)
• Total bilirubin ≤ 2 times ULN OR ≤ 3 times ULN (in the presence of liver metastases)
• Ejection fraction ≥ 50% by MUGA or 2-D echocardiogram
• Negative pregnancy test
• Fertile patients must use at least 1 highly effective and 1 additional effective contraception method 4 weeks prior to, during, and 3 months after completion of study therapy
• HIV-negative
• Must have sufficient mental capacity to understand the explanation of the study and to provide informed consent
• Willingness and ability to comply with the FDA-mandated S.T.E.P.S. program

Exclusion Criteria

• Pregnant or lactating
• Active, serious infections uncontrolled by antibiotics
• Any medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in this clinical trial
• History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or the components of doxorubicin hydrochloride liposome or bortezomib, boron, or mannitol
• Any of the following conditions:

• History of uncontrolled New York Heart Association class II-IV heart disease or clinical evidence of congestive heart failure
• Myocardial infarction within the past 6 months
• Uncontrolled angina
• Severe uncontrolled ventricular arrhythmias, ECG evidence of acute ischemia, or active conduction system abnormalities
• Peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelvin Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-I-59105

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000563183

Identifier Type: -

Identifier Source: org_study_id