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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: Doxil
Drug: Thalidomide
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Response rate [ Time Frame: At cycle 4 and end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: weekly during treatment, end of study ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: November 2002
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222105

Sponsors and Collaborators
University of Kansas
Ortho Biotech, Inc.
Investigators
Principal Investigator: Delva Deauna-Limayo, MD University of Kansas
  More Information

No publications provided

Responsible Party: Delva Deaunna-Limayo, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00222105     History of Changes
Other Study ID Numbers: Doxil
Study First Received: September 13, 2005
Last Updated: February 16, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Liposomal doxorubicin
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on October 22, 2014