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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

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Doxil Drug: Thalidomide Drug: Dexamethasone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Doxil® (Pegylated Liposomal Doxorubicin), Dexamethasone Plus Thalidomide (Ddt) in Previously Untreated Multiple Myeloma: A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life
Study Start Date : November 2002
Actual Primary Completion Date : April 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: 1
Doxil, Thalidomide, Dexamethasone
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: End of study, up to 12 months ]
    Count of Participants with adverse events.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00222105

Sponsors and Collaborators
University of Kansas Medical Center
Ortho Biotech, Inc.
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Principal Investigator: Delva Deauna-Limayo, MD University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center Identifier: NCT00222105     History of Changes
Other Study ID Numbers: Doxil
First Posted: September 22, 2005    Key Record Dates
Results First Posted: May 1, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
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Hemostatic Disorders
Liposomal doxorubicin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal