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Liposomal Doxorubicin, Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Multiple Myeloma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2009
First Received: February 20, 2009   Last Updated: August 20, 2009   History of Changes
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00849251
  Purpose

RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Giving liposomal doxorubicin together with bortezomib, cyclophosphamide, and dexamethasone may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects of giving liposomal doxorubicin together with bortezomib, cyclophosphamide, and dexamethasone and to see how well it works in treating patients with multiple myeloma.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: bortezomib
Drug: cyclophosphamide
Drug: dexamethasone
Drug: pegylated liposomal doxorubicin hydrochloride
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Combination Pegylated Liposomal Doxorubicin, Bortezomib, Cyclophosphamide, and Dexamethasone for Multiple Myeloma (PLD-BCD)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Toxicity (Phase I) [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate (Phase II) [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2009
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the toxicity of a novel combination regimen comprising pegylated liposomal doxorubicin hydrochloride, bortezomib, cyclophosphamide, and dexamethasone in patients with relapsed or refractory multiple myeloma. (Phase I)

Secondary

  • To determine the efficacy of this regimen in patients with newly diagnosed multiple myeloma. (Phase II)

OUTLINE: Patients receive cyclophosphamide IV over 1 hour, bortezomib IV over 3 minutes, and dexamethasone orally or IV on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma meeting one of the following criteria:

    • Relapsed or refractory disease (phase I)

      • Must have failed at least one prior regimen, not including dexamethasone alone
    • Newly diagnosed, previously untreated disease (phase II)

      • Prior dexamethasone allowed provided dose was ≤ 300 mg
  • Quantifiable monoclonal protein or light chain identified by serum protein electrophoresis, urine protein electrophoresis, or serum free light chain assay

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Serum creatinine ≤ 2.0 mg/dL
  • Serum bilirubin ≤ 1.2 mg/dL
  • AST/ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
  • LVEF ≥ 50% by MUGA
  • No other concurrent severe disease, history of serious organ dysfunction, or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk for undergoing study treatment
  • No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as exhibiting ongoing signs/symptoms related to the infection with no improvement, despite appropriate antibiotics or other treatment
  • No other malignancy within the past 3 years, except for the following:

    • Non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia for which patient has completed definitive treatment
    • Organ-confined prostate cancer with no evidence of recurrent or progressive disease based on PSA values for which patient has started hormonal therapy or has undergone a radical prostatectomy
  • No concurrent significant illness, condition, or psychiatric disorder that would compromise patient safety or compliance or that would interfere with informed consent, study participation, study follow-up, or interpretation of study results

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior allogeneic stem cell transplantation
  • No prior autologous stem cell transplantation (phase II)
  • No prior cumulative dose of doxorubicin hydrochloride ≥ 400 mg/m^2

    • This level must not be exceeded during study treatment
  • More than 30 days since prior anticancer therapy and recovered
  • No other concurrent chemotherapy, radiotherapy, or immunotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849251

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109-1024
Contact: Clinical Trials Office - Fred Hutchinson Cancer Research Cente     800-804-8824        
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Pamela S. Becker, MD, PhD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: University of Washington School of Medicine ( Pamela S. Becker )
Study ID Numbers: CDR0000634802, UWCC-6817, IR-6817, FHCRC-6817
Study First Received: February 20, 2009
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00849251     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Study placed in the following topic categories:
Anti-Inflammatory Agents
Dexamethasone
Immunologic Factors
Blood Protein Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Cyclophosphamide
Hemostatic Disorders
Hormones
Anti-Bacterial Agents
Hemorrhagic Disorders
Alkylating Agents
Dexamethasone acetate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Immunosuppressive Agents
Glucocorticoids
Doxorubicin
Protease Inhibitors
Multiple Myeloma
Antineoplastic Agents, Alkylating
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Antirheumatic Agents

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Cyclophosphamide
Antibiotics, Antineoplastic
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Alkylating Agents
Dexamethasone acetate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Bortezomib
Gastrointestinal Agents
Vascular Diseases
Enzyme Inhibitors
Glucocorticoids
Immunosuppressive Agents

ClinicalTrials.gov processed this record on August 30, 2009