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A Phase II Single Arm Study of VELCADE and DOXIL (PLD) in Patients With Relapsed Multiple Myeloma Previously Treated With VELCADE

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

A Phase II Single Arm Study of VELCADE and DOXIL (PLD) in Patients With Relapsed Multiple Myeloma Previously Treated With VELCADE

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

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:

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


United States: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

June 2010

Related Keywords:

  • Multiple Myeloma
  • pegylated liposomal doxorubicin
  • relapsed
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell