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Trial record 32 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life

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: NCT00222105
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : May 1, 2017
Last Update Posted : July 2, 2017
Ortho Biotech, Inc.
Information provided by (Responsible Party):
University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Results First Submitted Date  ICMJE March 21, 2017
Results First Posted Date  ICMJE May 1, 2017
Last Update Posted Date July 2, 2017
Study Start Date  ICMJE November 2002
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
Overall Response Rate [ Time Frame: At End of Cycle 1, 28 Days ]
Response rate after completion of first cycle. Measured as the proportion of subjects who have a partial response (PR) or complete response (CR), represented as the overall response rate (ORR). SWOG/IBMTR (Southwest Oncology Group/International Blood and Marrow Transplant Research) criteria utilized to determine multiple myeloma response rates.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00222105 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
Toxicity [ Time Frame: End of study, up to 12 months ]
Count of Participants with adverse events.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life
Official Title  ICMJE Doxil® (Pegylated Liposomal Doxorubicin), Dexamethasone Plus Thalidomide (Ddt) in Previously Untreated Multiple Myeloma: A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life
Brief Summary Four monthly treatments with pegylated liposomal doxorubicin, thalidomide and dexamethasone for newly diagnosed myeloma patients as induction therapy prior to high dose chemotherapy and autologous stem cell transplant.
Detailed Description

Multiple myeloma (MM) is an incurable hematological malignancy of plasma cell origin. Plasma cell clonality and dysfunctional immunoglobulin production characterize the disease. The consequences of abnormal plasma cell growth are manifested by a myriad of symptoms and signs that often have significant impact on the patient's quality of life. These include pancytopenia secondary to predominant distribution of tumor cells within the bone marrow along with many other effects.

This study is focused on the efficacy of Doxil® (pegylated liposomal doxorubicin) with low dose Dexamethasone and Thalidomide (Ddt) in previously untreated patients with multiple myeloma.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: Doxil
    Doxil 40 mg/m2 IV day 1
    Other Name: pegylated liposomal doxorubicin
  • Drug: Thalidomide
    50-100 mg day 1-28
    Other Name: thalidomid
  • Drug: Dexamethasone
    Dexamethasone 40 mg day 1-4 and 15-18
    Other Name: decadron
Study Arms  ICMJE Experimental: 1
Doxil, Thalidomide, Dexamethasone
  • Drug: Doxil
  • Drug: Thalidomide
  • Drug: Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2005)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with active, symptomatic multiple myeloma without prior chemotherapy:
  • Durie-Salmon Stage II-III A/B
  • Stage I patients with at least 2 of the poor prognostic indicators may be eligible.
  • Patients with plasma cell leukemia
  • Non-secretory multiple myeloma patients are eligible
  • Patients between the ages of 18 and 75 years old
  • Female Patients of child bearing age (up to age 50) who are not pregnant and agree to use two adequate birth control methods during the study and at least six months after treatment unless patient has undergone hysterectomy or has been in menopause for 2 years.
  • Patients with Southwest Oncology Group (SWOG) performance status of 3 or better
  • Patients who have received prior lower dose Dexamethasone Therapy (ie. 4 mg QID) as adjunct to radiation therapy for cord compression may be eligible
  • All patients must have a MUGA scan indicating a left ventricular ejection fraction (LVEF) of greater than or equal to 50% within 42 days prior to registration
  • Must be able to understand English.
  • Must be willing and eligible to sign up for the STEPS program

Exclusion Criteria:

  • Nursing mothers or women who are pregnant
  • Patients with a history of hypersensitivity reaction to doxorubicin or agents in Doxil®
  • Patients with previous malignancies at other sites except surgically treated nonmelanomatous skin cancers, prostate cancer or superficial cervical cancers, or other cancer from which the patient had been disease free for 5 or more years.
  • History of mediastinal radiation for any reason
  • History of receiving prior anthracyclines
  • Patients with uncontrolled medical problems such as diabetes mellitus, cardiac, pulmonary, hepatic, and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma
  • Myocardial infarction within 6 months of enrollment in the study.
  • Major surgery within 4 weeks of enrollment.
  • Patients previously treated or receiving other treatment for multiple myeloma other than lower doses dexamethasone as adjunct to radiotherapy
  • Pre-existing peripheral neuropathy
  • Patients with previously diagnosed malabsorption syndromes or anatomical abnormalities of the gastrointestinal tract that result in malabsorption syndromes.
  • Patients with a history of cardiac disease, defined as New York Heart Association Class II or greater, or clinical evidence of congestive heart failure.
  • Patients with psychiatric or central nervous systems disorders interfering with compliance of orally administered medication.
  • Patients currently receiving anticoagulant therapy for venous thromboembolic episode or other hypercoagulable states.
  • Patients who are unable to understand the English language.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
Administrative Information
NCT Number  ICMJE NCT00222105
Other Study ID Numbers  ICMJE Doxil
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE Ortho Biotech, Inc.
Investigators  ICMJE
Principal Investigator: Delva Deauna-Limayo, MD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP