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

This study has been withdrawn prior to enrollment.
(This study was cancelled due to lack of enrollment.)
Sponsor:
Collaborator:
Centocor Ortho Biotech Services, L.L.C.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00706953
First received: June 26, 2008
Last updated: April 23, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: bortezomib; pegylated liposomal doxorubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Single Arm Study of VELCADE and DOXIL (PLD) in Patients With Relapsed Multiple Myeloma Previously Treated With VELCADE

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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. [ Time Frame: Assessed at each 21-day treatment cycle up to 8 cycles and over 6 months following discontinuation of all study drugs. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). [ Time Frame: Day 1, Cycle 1 throughout treatment cycles and follow-up. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2008
Estimated Study Completion Date: June 2010
Arms Assigned Interventions
Active Comparator: 001 Drug: bortezomib; pegylated liposomal doxorubicin
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

Detailed Description:

The primary purpose of this study is to evaluate the overall response rate to DOXIL/VELCADE treatment in patients with relapsed multiple myeloma previously treated with VELCADE. Overall response rate is defined as the proportion of patients achieving either a complete response (CR) or partial response (PR) to treatment according to the European Group for Blood and Marrow Transplantation (EBMT) criteria. This is a single arm (all patients will receive the same drug combination and dose), multi-center (many study sites), open label (the patient and the physician know the drug treatment being received) of approximately 60 patients with multiple myeloma whose disease has progressed after initial response to VELCADE-based therapy. During each 21-day treatment cycle, patients will receive VELCADE by intravenous bolus on 4 designated days, and DOXIL by intravenous infusion on one designated day. Treatment will continue until disease progression, or the occurrence of unacceptable treatment-related toxicity or up to a total of 8 cycles of therapy. Drug doses may be delayed or dropped as needed to allow for platelet transfusions or other treatment requirements. Patients responding to treatment at study end may be evaluated for continued treatment for as long as treatment can be tolerated and they continue to respond. After discontinuation of all study drugs, patients who have not had disease progression will be followed for 6 months after receiving the last dose of study drug. The primary endpoint is overall response rate as defined by the proportion of patients achieving either a complete response or a partial response. Response will be assessed at each cycle. Safety will be monitored throughout the study by physical examination, clinical laboratory testing, and the incidence and severity of reported adverse events. Overall safety will be summarized at study-end.

During each 21-day treatment cycle, patients will receive bortezomib 1.3 mg/m2 by intravenous bolus on Days 1, 4, 8 and 11 and pegylated liposomal doxorubicin 30 mg/m2 by intravenous infusion on Day 4.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 60 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706953

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Centocor Ortho Biotech Services, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Vice President Medical Affairs Oncology/Nephrology, Ortho Biotech Products, L.P.
ClinicalTrials.gov Identifier: NCT00706953     History of Changes
Other Study ID Numbers: CR015091, DOXILMMY2009
Study First Received: June 26, 2008
Last Updated: April 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
pegylated liposomal doxorubicin
VELCADE
DOXIL
relapsed
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Liposomal doxorubicin
Doxorubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014