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Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bort, Dex, and Dox with ALCAR
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring previously treated multiple myeloma

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with previously treated multiple myeloma with measurable serum or urine monoclonal protein.

Exclusion Criteria:

  • Patients with previous doxorubicin treatment totaling 220 mg/m2 or more
  • LVEF less than 45%
  • Patients with >grade II sensory neuropathy at baseline as assessed by the PI will be excluded
  • No history of seizures as ALCAR may lower the seizure threshold
  • Known HIV infection
  • Current pregnancy.

Sites / Locations

  • Mercy Health Systems
  • Gundersen Lutheran
  • University of Wisconsin Cancer Center
  • Regional Cancer Center
  • Aspirus Wausau Hospital, Aspirus Regional Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bort, Dex, and Dox with ALCAR

Arm Description

Outcomes

Primary Outcome Measures

Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR
Anti-tumor responses were analyzed descriptively and summarized in tabular format. Ninety percent confidence intervals for the percentage of subjects with a confirmed anti-tumor response were constructed using the method proposed by Duffy-Santner. Complete response defined as: no evidence of M-protein on immunofixation of serum and/or urine AND less than 5% plasma cells in the bone marrow biopsy. Partial response defined as: 50 to 99% decrease in M-protein on serum and/or urine protein electrophoresis.

Secondary Outcome Measures

Overall Survival
Progression-free Survival
Progression is defined as any of the following: 1) 25% or greater increase in M-protein as measured by serum or urine protein electrophoresis. There must be an absolute minimum increase of 0.5 g/dl in serum M spike or 0.2 gram of specific urinary light chains to constitute progression, 2) 25% or greater increase in the percentage or plasma cells in the bone marrow biopsy, or 3) new bone lesions or an increase in the size of old lesions on x-ray.

Full Information

First Posted
December 19, 2007
Last Updated
December 11, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00581919
Brief Title
Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma
Official Title
Phase II Trial of Bortezomib, Low Dose Dexamethasone, and Doxorubicin With Acetyl-L-Carnitine for Neuroprotection in Patients With Previously Treated Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients will receive Bortezomib, Dexamethasone, and Doxorubicin in 21 day cycles a total of 4 to 8 times (based on response to the treatment). Patients will also receive acetyl-L-carnitine (ALCAR) daily.
Detailed Description
The primary objective of this study is to assess overall response rate to the treatment. Secondary objectives include: evaluating and describing the incidence of chemotherapy-induced peripheral neuropathy using the FACT/GOG-Ntx assessment tool; evaluating the utility of adding ALCAR to the chemotherapy to reduce the incidence of peripheral neuropathy; and evaluating the utility of the Grooved Pegboard Completion Time as a longitudinal measure of peripheral neuropathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
previously treated 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
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bort, Dex, and Dox with ALCAR
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bort, Dex, and Dox with ALCAR
Other Intervention Name(s)
Velcade, cc-5013, ALCAR
Intervention Description
Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
Primary Outcome Measure Information:
Title
Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR
Description
Anti-tumor responses were analyzed descriptively and summarized in tabular format. Ninety percent confidence intervals for the percentage of subjects with a confirmed anti-tumor response were constructed using the method proposed by Duffy-Santner. Complete response defined as: no evidence of M-protein on immunofixation of serum and/or urine AND less than 5% plasma cells in the bone marrow biopsy. Partial response defined as: 50 to 99% decrease in M-protein on serum and/or urine protein electrophoresis.
Time Frame
Every 21 days, up to 24 weeks
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
From date of randomization until the date of death from any cause, assessed up to 7 years
Title
Progression-free Survival
Description
Progression is defined as any of the following: 1) 25% or greater increase in M-protein as measured by serum or urine protein electrophoresis. There must be an absolute minimum increase of 0.5 g/dl in serum M spike or 0.2 gram of specific urinary light chains to constitute progression, 2) 25% or greater increase in the percentage or plasma cells in the bone marrow biopsy, or 3) new bone lesions or an increase in the size of old lesions on x-ray.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with previously treated multiple myeloma with measurable serum or urine monoclonal protein. Exclusion Criteria: Patients with previous doxorubicin treatment totaling 220 mg/m2 or more LVEF less than 45% Patients with >grade II sensory neuropathy at baseline as assessed by the PI will be excluded No history of seizures as ALCAR may lower the seizure threshold Known HIV infection Current pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie S Callander, MD
Organizational Affiliation
UWCCC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Health Systems
City
Janesville
State/Province
Wisconsin
Country
United States
Facility Name
Gundersen Lutheran
City
La Crosse
State/Province
Wisconsin
Country
United States
Facility Name
University of Wisconsin Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Regional Cancer Center
City
Waukesha/Oconomowoc
State/Province
Wisconsin
Country
United States
Facility Name
Aspirus Wausau Hospital, Aspirus Regional Cancer Center
City
Wausau
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

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Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma

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