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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00222105
• Other study ID #: Doxil
• Status: Withdrawn
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: February 16, 2011
• Start date: November 2002
• Est. completion date: July 2009

Study information

• Verified date: February 2011
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 25
• Est. completion date: July 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Doxil
Doxil 40 mg/m2 IV day 1
• Thalidomide
50-100 mg day 1-28
• Dexamethasone
Dexamethasone 40 mg day 1-4 and 15-18

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Ortho Biotech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		At cycle 4 and end of study	No
Secondary	Toxicity		weekly during treatment, end of study	Yes