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

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

bortezomib

pegylated liposomal doxorubicin hydrochloride

thalidomide

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Diagnosis of stage I, II, or III multiple myeloma requiring therapy
No prior systemic therapy for multiple myeloma
- Patients who have received steroids or radiotherapy for cord compression or spinal cord disease are eligible for this study
- 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:

Inclusion criteria:

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

Sites / Locations

Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

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

Outcomes

Primary Outcome Measures

Overall Response Rate (Complete and Partial)

Secondary Outcome Measures

Complete Response Rate

Time to Disease Progression

Full Information

NCT ID

NCT00523848

First Posted

August 31, 2007

Last Updated

January 9, 2017

Sponsor

Roswell Park Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT00523848

Brief Title

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

Official Title

Phase II Study of VDT (VELCADE, Doxil® and Thalidomide) as Frontline Therapy for Patients With Previously Untreated Multiple Myeloma (MM)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

bortezomib

Intervention Description

Intervention Type

Drug

Intervention Name(s)

pegylated liposomal doxorubicin hydrochloride

Intervention Description

Intervention Type

Drug

Intervention Name(s)

thalidomide

Intervention Description

Oral

Primary Outcome Measure Information:

Title

Overall Response Rate (Complete and Partial)

Time Frame

Every 3 months

Secondary Outcome Measure Information:

Title

Complete Response Rate

Time Frame

Every 3 months

Title

Time to Disease Progression

Time Frame

Every 3 monthsntil the date of first documented progression or date of death from any cause, whichever came first

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Diagnosis of stage I, II, or III multiple myeloma requiring therapy No prior systemic therapy for multiple myeloma Patients who have received steroids or radiotherapy for cord compression or spinal cord disease are eligible for this study 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: Inclusion criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kelvin Lee, MD

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263-0001

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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