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Doxil® (Pegylated Liposomal Doxorubicin), Dexamethasone Plus Thalidomide (Ddt) in Previously Untreated Multiple Myeloma: A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life

Phase 2
18 Years
75 Years
Not Enrolling
Multiple Myeloma

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Trial Information

Doxil® (Pegylated Liposomal Doxorubicin), Dexamethasone Plus Thalidomide (Ddt) in Previously Untreated Multiple Myeloma: A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life

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

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

At cycle 4 and end of study

Safety Issue:


Principal Investigator

Delva Deauna-Limayo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Food and Drug Administration

Study ID:




Start Date:

November 2002

Completion Date:

July 2009

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell