A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma

NCT00097981 | Completed Phase 3 Results DMC

• 2 other identifiers: CR004579DO04-23-006
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 58

Brief Summary

The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (complete Response) will be studied to make the determination of which treatment is more effective.

Conditions

Multiple Myeloma

Keywords

Multiple myeloma; Newly diagnosed multiple myeloma; Thalidomide; Dexamethasone; DOXIL; Pegylated liposomal hydrochloride doxorubicin injection

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate: Number of Participants Who Achieved a Complete Response

  Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle 2.

  From Cycle 2 until 28 days following completion of treatment

Secondary Outcomes (6)

• Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)

  From Cycle 2 until 28 days following completion of treatment

• Time to 1st Response

  From Cycle 2 until 28 days following completion of treatment

• Time to Progression

  From randomization until death or as assessed up to 2 years post last participant last treatment visit

• Overall Survival: Number of Participants Died Due to Any Cause

  From randomization until death or as assessed up to 2 years post last participant last treatment visit

• Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow)

  From randomization until death or as assessed up to 2 years post last participant last treatment visit

Study Arms (2)

Thalidomide + dexamethasone

ACTIVE COMPARATOR

Drug: Thalidomide; Drug: Dexamethasone

Thalidomide + dexamethasone + DOXIL

EXPERIMENTAL

Drug: Thalidomide; Drug: Dexamethasone; Drug: DOXIL

Interventions

Thalidomide DRUG

Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered for subsequent cycles. Participants will receive thalidomide for minimum of 4 cycles and a maximum of 12 cycles.

Thalidomide + dexamethasone; Thalidomide + dexamethasone + DOXIL

Dexamethasone DRUG

Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20.

Thalidomide + dexamethasone; Thalidomide + dexamethasone + DOXIL

DOXIL DRUG

DOXIL 40 mg/m2 will be administered iintravenously (into a vein) on Day 1.

Thalidomide + dexamethasone + DOXIL

Eligibility Criteria

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

You may qualify if:

• Previously untreated, histologically confirmed multiple myeloma (per International Myeloma Working Group \[IMWG\] criteria
• Eastern Cooperative Oncology Group (ECOG) status 0-2
• Adequate absolute neutrophil count (ANC), platelet count and hemoglobin
• Adequate serum calcium
• Enrollment in System for Thalidomide Education and Prescribing Safety Program (S.T.E.P.S.)

You may not qualify if:

• No treatment with dexamethasone for multiple myeloma
• No peripheral neuropathy of Grade 2 or higher
• No Left Ventricular Ejection Fraction (LVEF) of less than 45 percentage
• No history of life-threatening thromboembolic events of any kind (ie, myocardial infarction, pulmonary embolism, stroke or others), within 1 year before enrollment in the study
• No deep vein thrombosis (DVT) within 1 year of enrollment
• No current anticoagulation for DVT

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA: collaborator

Study Sites (58)

Unknown Facility

Fountain Valley, California, United States

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Greenbrae, California, United States

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La Verne, California, United States

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Los Angeles, California, United States

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Denver, Colorado, United States

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New London, Connecticut, United States

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Boca Raton, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Orange City, Florida, United States

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Ormond Beach, Florida, United States

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Lawrenceville, Georgia, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Wichita, Kansas, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Minneapolis, Minnesota, United States

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Saint Louis Park, Minnesota, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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Omaha, Nebraska, United States

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Englewood, New Jersey, United States

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Hackensack, New Jersey, United States

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Jersey City, New Jersey, United States

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Voorhees Township, New Jersey, United States

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Albany, New York, United States

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Armonk, New York, United States

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Box 302, New York, United States

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Brooklyn, New York, United States

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Nyack, New York, United States

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The Bronx, New York, United States

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Valhalla, New York, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Wynnewood, Pennsylvania, United States

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Columbia, South Carolina, United States

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Easley, South Carolina, United States

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Sumter, South Carolina, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Bedford, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Fredericksburg, Texas, United States

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Houston, Texas, United States

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Burlington, Vermont, United States

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Fairfax, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Spokane, Washington, United States

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Vancouver, Washington, United States

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Yakima, Washington, United States

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MeSH Terms

Conditions

Multiple Myeloma

Interventions

Thalidomide; Dexamethasone; liposomal doxorubicin

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

Results Point of Contact

• Title: Medical Director
• Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

1 215 325-5329

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2004
• First Posted: December 2, 2004
• Study Start: January 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2009
• Last Updated: April 7, 2017
• Results First Posted: November 27, 2008

Record last verified: 2017-02

Locations

US (58)