Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been withdrawn prior to enrollment.
(PI left institution, study closed September 2009)
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00222105
First received: September 13, 2005
Last updated: February 16, 2011
Last verified: February 2011

September 13, 2005
February 16, 2011
November 2002
April 2009   (final data collection date for primary outcome measure)
Response rate [ Time Frame: At cycle 4 and end of study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00222105 on ClinicalTrials.gov Archive Site
Toxicity [ Time Frame: weekly during treatment, end of study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life
Doxil® (Pegylated Liposomal Doxorubicin), Dexamethasone Plus Thalidomide (Ddt) in Previously Untreated Multiple Myeloma: A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • 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
Experimental: 1
Doxil, Thalidomide, Dexamethasone
Interventions:
  • Drug: Doxil
  • Drug: Thalidomide
  • Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
25
July 2009
April 2009   (final data collection date for primary outcome measure)

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 following poor prognostic indicators may be eligible: A. M component IgG ≥ 3.0g/dL IgA ≥ 2.5g/dL B. Unfavorable cytogenetics (abnormality of chromosome 13q) detected by karyotype or FISH analysis C. B2M Levels or CRP ≥ 4mg/L D. Hemoglobin < 12g/dL E. Bone marrow plasmacytosis >25% F. Plasmablastic morphology (>2% plasmablasts in the aspirate)
  • 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 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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00222105
Doxil
Yes
Delva Deaunna-Limayo, University of Kansas Medical Center
University of Kansas
Ortho Biotech, Inc.
Principal Investigator: Delva Deauna-Limayo, MD University of Kansas
University of Kansas
February 2011

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