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Doxorubicin Hydrochloride Liposome, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00742404
Recruitment Status : Unknown
Verified June 2010 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : August 27, 2008
Last Update Posted : December 18, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and dexamethasone, 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 tumor. Giving bortezomib together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome together with bortezomib and dexamethasone works in treating patients with newly diagnosed multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: bortezomib Drug: dexamethasone Drug: pegylated liposomal doxorubicin hydrochloride Genetic: protein analysis Other: immunologic technique Phase 2

Detailed Description:



  • To determine the response rate (i.e., complete response, very good partial response , partial response, and minimal response) in patients with newly diagnosed multiple myeloma treated with pegylated liposomal doxorubicin hydrochloride, bortezomib, and dexamethasone.


  • To assess the safety and tolerability of this regimen in these patients.
  • To determine the time to disease progression, time to response, duration of response, progression-free survival, and overall survival of patients treated with this regimen.

OUTLINE: Patients receive pegylated liposomal doxorubicin hydrochloride IV over 30-90 minutes, dexamethasone IV, and bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Blood and urine samples are collected at baseline and periodically during study for M-protein analysis by electrophoresis and immunofixation.

After completion of study therapy, patients are followed periodically.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Pegylated Liposomal Doxorubicin, Bortezomib and Dexamethasone (DVD) for Patients With Newly Diagnosed Multiple Myeloma (MM)
Study Start Date : July 2008
Estimated Primary Completion Date : July 2010

Primary Outcome Measures :
  1. Response rate (complete response, very good partial response, partial response, and minimal response) as assessed by modified Bladé criteria at baseline, on day 1 of each course, and at end-of-study

Secondary Outcome Measures :
  1. Safety and tolerability as assessed by NCI CTCAE v3.0
  2. Time to progression
  3. Time to response
  4. Duration of response
  5. Progression-free survival
  6. Overall survival
  7. Changes in serum M-protein
  8. Changes in 24-hour urine M-protein

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of multiple myeloma based on the following criteria:

    • Major criteria

      • Plasmacytomas on tissue biopsy (1)
      • Bone marrow plasmacytosis (> 30% plasma cells) (2)
      • Monoclonal immunoglobulin spike on serum electrophoresis IgG > 3.5 g/dL or IgA > 2.0 g/dL and kappa or lambda light chain excretion > 1 g/day on 24-hour urine protein electrophoresis (3)
    • Minor criteria

      • Bone marrow plasmacytosis (10% to 30% plasma cells) (a)
      • Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria (b)
      • Lytic bone lesions (c)
      • Normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL (d)
  • Meets 1 of the following sets of diagnostic criteria:

    • Any two of the major criteria
    • Major criteria 1 and minor criteria b, c, and d
    • Major criteria 3 and minor criteria a or c
    • Minor criteria a, b, c, OR a, b, d
  • Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis ≥ 1 g/dL and/or urine monoclonal immunoglobulin spike ≥ 200 mg/24 hours, or evidence of lytic bone disease

    • No nonmeasurable disease (i.e., non-secretory or oligosecretory multiple myeloma)
  • Symptomatic, newly diagnosed, and previously untreated multiple myeloma
  • No POEMS syndrome (i.e., plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein], and skin changes)
  • No plasma cell leukemia


  • Karnofsky performance status 60-100%
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm^³ (≥ 1,000/mm^³ if bone marrow is extensively infiltrated)
  • Platelet count ≥ 75,000/mm^³ (≥ 50,000/mm^³ if bone marrow is extensively infiltrated)
  • Hemoglobin ≥ 8.0 g/dL
  • AST and ALT ≤ 3.0 times upper limit of normal (ULN)
  • Serum bilirubin ≤ 2.0 times ULN
  • Creatinine clearance ≥ 30 mL/min OR creatinine > 10 mL/min and < 30 mL/min for patients with significant myelomatous involvement of the kidneys
  • Serum potassium ≥ lower limit of normal (LLN)
  • Serum sodium ≥ LLN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No peripheral neuropathy ≥ grade 2 within past 14 days
  • No impaired cardiac function or clinically significant cardiac disease, including any one of the following:

    • Myocardial infarction within the past 6 months
    • New York Heart Association class II-IV heart failure
    • Uncontrolled angina
    • Clinically significant pericardial disease
    • Severe uncontrolled ventricular arrhythmias
    • LVEF below normal by ECHO or MUGA scan
    • ECG evidence of acute ischemia or active conduction system abnormalities

      • Screening ECG abnormality must be documented by the investigator as not medically relevant
  • No severe hypercalcemia (i.e., serum calcium ≥ 14 mg/dL [3.5 mmol/L])
  • No poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could preclude study treatment
  • No known HIV positivity or hepatitis B or C positivity

    • Baseline testing for HIV and hepatitis B or C is not required
  • No history of allergic reaction attributable to compounds of similar chemical or biological composition to doxorubicin, bortezomib, boron, or mannitol


  • See Disease Characteristics
  • No prior or concurrent anti-myeloma therapy except steroids

    • Prior prednisone for ≤ 4 days at a total of 400 mg (or an equivalent potency of another steroid) allowed
    • No concurrent corticosteroids (≥ 10 mg prednisone/day or equivalent) other than dexamethasone
  • More than 4 weeks since prior major surgery and recovered

    • Prior kyphoplasty with oncotherapeutic drugs allowed at the investigator's discretion
  • More than 4 weeks since prior immunotherapy, antibody therapy, or radiotherapy
  • More than 14 days since other prior and no other concurrent investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00742404

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United States, Arizona
Arizona Clinical Research Center, Incorporated
Tucson, Arizona, United States, 85712
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309-0633
San Diego Pacific Oncology and Hematology Associates, Incorporated - Escondido
Escondido, California, United States, 92025
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Oncology Care Medical Associates - San Gabriel
Los Angeles, California, United States, 90057
Desert Cancer Care
Rancho Mirage, California, United States, 92270
Sutter Cancer Center at Roseville Medical Center
Roseville, California, United States, 95661
Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara
Santa Barbara, California, United States, 93105
James R. Berenson MD, Incorporated
West Hollywood, California, United States, 90069
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, New York
New York Medical College
Valhalla, New York, United States, 10595
United States, South Carolina
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
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Principal Investigator: James R. Berenson, MD Oncotherapeutics

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Responsible Party: Regulatory Affairs Associate, Oncotherapeutics Identifier: NCT00742404     History of Changes
Other Study ID Numbers: CDR0000612434
DVD study
First Posted: August 27, 2008    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: June 2010
Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Liposomal doxorubicin
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists