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

NCT00222105 | Completed Phase 2 Results DMC

• 1 other identifier: Doxil
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  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.

  At End of Cycle 1, 28 Days

Secondary Outcomes (1)

• Toxicity

  End of study, up to 12 months

Study Arms (1)

1

EXPERIMENTAL

Doxil, Thalidomide, Dexamethasone

Drug: Doxil; Drug: Thalidomide; Drug: Dexamethasone

Interventions

Doxil DRUG

Doxil 40 mg/m2 IV day 1

Also known as: pegylated liposomal doxorubicin

1

Thalidomide DRUG

50-100 mg day 1-28

Also known as: thalidomid

1

Dexamethasone DRUG

Dexamethasone 40 mg day 1-4 and 15-18

Also known as: decadron

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Ortho Biotech, Inc.: collaborator

MeSH Terms

Conditions

Multiple Myeloma

Interventions

liposomal doxorubicin; Thalidomide; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Cancer Center Clinical Trials Office
• Organization: University of Kansas Medical Center

SWILLIAM@kumc.edu

(913) 945-5059

Study Officials

• Delva Deauna-Limayo, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2002
• Primary Completion: April 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 2, 2017
• Results First Posted: May 1, 2017

Record last verified: 2017-06