A Study of Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed Multiple Myeloma Previously Treated With Bortezomib

NCT00706953 | Withdrawn Phase 2

• 2 other identifiers: CR015091DOXILMMY2009
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of using pegylated liposomal doxorubicin and bortezomib in the treatment of patients with relapsed multiple myeloma who had been previously treated with bortezomib. Multiple myeloma is a cancer that begins in plasma cells, a type of white blood cell. These cells are part of the immune system, which helps protect the body from germs and other harmful substances. In time, myeloma cells collect in the bone marrow and in the solid parts of bone. Multiple myeloma treatment may include stem cell transplantation, however, not all patients with multiple myeloma are candidates for stem cell transplantation and many patients who receive transplants relapse. As a result, additional first and later-line therapeutic options are needed for patients who are not candidates for transplantation, or whose disease relapses after transplantation or other therapies. Pegylated liposomal doxorubicin in combination with bortezomib is approved for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. The combined use of pegylated liposomal doxorubicin and bortezomib in this study is designed to evaluate the overall response rate and safety in patients with multiple myeloma who have been previously treated with bortezomib.

Conditions

Multiple Myeloma

Keywords

pegylated liposomal doxorubicin; VELCADE; DOXIL; relapsed; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the overall response rate defined as the partial or complete response to treatment according to EBMT criteria. Overall response will be assessed at each treatment cycle up to 8 cycles.

  Assessed at each 21-day treatment cycle up to 8 cycles and over 6 months following discontinuation of all study drugs.

Secondary Outcomes (1)

• Secondary endpoints include time to disease progression (treatment start to disease progression or death due to progression); best response assessed by the investigator; duration of response; and overall survival (treatment start to death by any cause).

  Day 1, Cycle 1 throughout treatment cycles and follow-up.

Study Arms (1)

001

ACTIVE COMPARATOR

Drug: bortezomib; pegylated liposomal doxorubicin

Interventions

bortezomib; pegylated liposomal doxorubicin DRUG

1.3 mg/m2 IV bolus on Days 1,4,8,11 of each 21-day cycle; 30 mg/m2 IV infusion on Day 4 of each 21 day cycle

001

Eligibility Criteria

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

You may qualify if:

• Confirmed diagnosis of Multiple Myeloma
• Received prior courses of bortezomib (VELCADE)-based therapy
• Greater than or equal to 50% reduction in M-Protein sustained for a minimum of 60 days and no evidence of progression of disease while on the most recent course of VELCADE-based therapy
• days or more since the patient's last VELCADE dose
• Life expectancy \> 3 months
• Progressive disease defined by new or worsening lytic bone lesions or plasmacytoma or hypercalcemia or a \>25% increase in M-protein

You may not qualify if:

• No patients with progressive disease while receiving an anthracycline-based regimen
• No patients with \>2 prior regimens for the treatment of multiple myeloma
• No major surgery within 2 weeks before screening
• No patients with history of allergic reaction to compounds containing boron, mannitol, anthracycline, or liposomal formulations of any agent
• No patients known to be human immunodeficiency virus (HIV) positive
• No patients with poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness
• No patients with an active systemic infection requiring treatment

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Centocor Ortho Biotech Services, L.L.C.: collaborator

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

Bortezomib; liposomal doxorubicin

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 6, 2015

Record last verified: 2015-04