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

NCT00581919 | Completed Phase 2 Results DMC

• 5 other identifiers: HO04402H-2004-0064A534260SMPH\MEDICINE\HEM-ONCNCI-2011-00516
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 5

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.

Conditions

Multiple Myeloma

Keywords

previously treated multiple myeloma

Outcome Measures

Primary Outcomes (1)

• 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.

  Every 21 days, up to 24 weeks

Secondary Outcomes (2)

• Overall Survival

  From date of randomization until the date of death from any cause, assessed up to 7 years

• Progression-free Survival

  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.

Study Arms (1)

Bort, Dex, and Dox with ALCAR

EXPERIMENTAL

Drug: Bort, Dex, and Dox with ALCAR

Interventions

Bort, Dex, and Dox with ALCAR DRUG

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

Also known as: Velcade, cc-5013, ALCAR

Bort, Dex, and Dox with ALCAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (5)

Mercy Health Systems

Janesville, Wisconsin, United States

Location

Gundersen Lutheran

La Crosse, Wisconsin, United States

Location

University of Wisconsin Cancer Center

Madison, Wisconsin, 53792, United States

Location

Regional Cancer Center

Waukesha/Oconomowoc, Wisconsin, United States

Location

Aspirus Wausau Hospital, Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Doxorubicin; Acetylcarnitine; Bortezomib; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Natalie Callander
• Organization: University of Wisconsin Hospital and Clinics

nsc@medicine.wisc.edu

608-265-8690

Study Officials

• Natalie S Callander, MD

  UWCCC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: February 1, 2004
• Primary Completion: December 1, 2010
• Study Completion: July 1, 2013
• Last Updated: December 13, 2019
• Results First Posted: August 24, 2016

Record last verified: 2016-11

Locations

US (5)