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

• Sponsor: University of Kansas Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00222105
• Collaborator: Ortho Biotech, Inc. (Industry)
• Enrollment: 25
• Arm: 1
• Duration (Months): 80

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• 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: Nov 1, 2002
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Doxil, Thalidomide, Dexamethasone	Drug: Doxil; Doxil 40 mg/m2 IV day 1; Other Names: pegylated liposomal doxorubicin ; Drug: Thalidomide; 50-100 mg day 1-28; Other Names: thalidomid ; Drug: Dexamethasone; Dexamethasone 40 mg day 1-4 and 15-18; Other Names: decadron

Outcome Measures

Primary Outcome Measures

1. Overall Response Rate [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 [End of study, up to 12 months]

   Count of Participants with adverse events.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Kansas Medical Center
• Ortho Biotech, Inc.

Investigators

• Principal Investigator: Delva Deauna-Limayo, MD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT00222105
• Other Study ID Numbers: Doxil
• First Posted: Sep 22, 2005
• Last Update Posted: Jul 2, 2017
• Last Verified: Jun 1, 2017

• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Thalidomide; Dexamethasone; Doxorubicin; Liposomal doxorubicin

Study Results

Participant Flow

Arm/Group Title	Arm 1
Arm/Group Description	Doxil, Thalidomide, Dexamethasone 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
Period Title: Overall Study
STARTED	25
COMPLETED	11
NOT COMPLETED	14

Baseline Characteristics

Arm/Group Title	Arm 1
Arm/Group Description	Doxil, Thalidomide, Dexamethasone 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
Overall Participants	25
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	61
Sex: Female, Male (Count of Participants)
Female	8 32%
Male	17 68%
Region of Enrollment (Count of Participants)
United States	25 100%

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate
Description	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.
Time Frame	At End of Cycle 1, 28 Days

Outcome Measure Data

Analysis Population Description

Five subjects did not complete first cycle.

Arm/Group Title	Arm 1
Arm/Group Description	Doxil, Thalidomide, Dexamethasone 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
Measure Participants	20
Number [percentage of participants]	95 380%

2. Secondary Outcome

Title	Toxicity
Description	Count of Participants with adverse events.
Time Frame	End of study, up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1
Arm/Group Description	Doxil, Thalidomide, Dexamethasone 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
Measure Participants	25
Count of Participants [Participants]	10 40%

Adverse Events

Arm/Group Title	Arm 1
Arm/Group Description	Doxil, Thalidomide, Dexamethasone 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
All Cause Mortality
	Arm 1
	Affected / at Risk (%)	# Events
Total	2/25 (8%)
Serious Adverse Events
	Arm 1
	Affected / at Risk (%)	# Events
Total	8/25 (32%)
Cardiac disorders
Arrhythmia	1/25 (4%)	1
Infections and infestations
Infection	5/25 (20%)	5
Metabolism and nutrition disorders
Dehydration	1/25 (4%)	1
Renal and urinary disorders
Acute Renal Failure	1/25 (4%)	1
Other (Not Including Serious) Adverse Events
	Arm 1
	Affected / at Risk (%)	# Events
Total	0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.