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Multiple MyelomaPhase 3NCT00097981

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

A Phase 3 study testing Thalidomide, Dexamethasone and DOXIL in people with Multiple Myeloma, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 58 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Thalidomide, Dexamethasone and DOXIL
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
58 sitesUnited States
Study dates
Jan 2005to Oct 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)

Who cannot join

  • 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

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

United States58 sites

  • Study site

    Albany, New York

  • Study site

    Armonk, New York

  • Study site

    Baltimore, Maryland

  • Study site

    Bedford, Texas

  • Study site

    Bethesda, Maryland

  • Study site

    Boca Raton, Florida

  • Study site

    Box 302, New York

  • Study site

    Brooklyn, New York

  • Study site

    Burlington, Vermont

  • Study site

    Chicago, Illinois

  • Study site

    Cleveland, Ohio

  • Study site

    Columbia, Missouri

  • Study site

    Columbia, South Carolina

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Durham, North Carolina

  • Study site

    Easley, South Carolina

  • Study site

    Englewood, New Jersey

  • Study site

    Eugene, Oregon

  • Study site

    Fairfax, Virginia

  • Study site

    Fort Worth, Texas

  • Study site

    Fountain Valley, California

  • Study site

    Fredericksburg, Texas

  • Study site

    Greenbrae, California

  • Study site

    Hackensack, New Jersey

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, Florida

  • Study site

    Jersey City, New Jersey

  • Study site

    Kansas City, Missouri

  • Study site

    La Verne, California

  • Study site

    Lawrenceville, Georgia

  • Study site

    Los Angeles, California

  • Study site

    Memphis, Tennessee

  • Study site

    Miami, Florida

  • Study site

    Minneapolis, Minnesota

  • Study site

    Nashville, Tennessee

  • Study site

    New London, Connecticut

  • Study site

    Norfolk, Virginia

  • Study site

    Nyack, New York

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orange City, Florida

  • Study site

    Ormond Beach, Florida

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Richmond, Virginia

  • Study site

    Saint Louis Park, Minnesota

  • Study site

    Spokane, Washington

  • Study site

    Sumter, South Carolina

  • Study site

    The Bronx, New York

  • Study site

    Tulsa, Oklahoma

  • Study site

    Valhalla, New York

  • Study site

    Vancouver, Washington

  • Study site

    Voorhees Township, New Jersey

  • Study site

    Wichita, Kansas

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Wynnewood, Pennsylvania

  • Study site

    Yakima, Washington

Other trials in United States

About this study

Official title: A Randomized, Open-Label, Multi-Center Trial Comparing Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Subjects With Newly Diagnosed Multiple Myeloma

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.

Read the detailed description

This is a multi-center, open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance) study to compare the safety and effectiveness of Thalidomide + Dexamethasone versus DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone in patients with newly diagnosed multiple myeloma. Treatments are administered in 28-day cycles. Patients will receive 4 to 12 treatment cycles, depending on the response of their multiple myeloma to the treatment (measured according to the European Group for Blood and Marrow Transplant Response Criteria). Patients will have additional tests that include Multiple Gated Acquisition (MUGA) scans or echocardiograms to assess the patients for potential cardiotoxicity that could be related to treatment with DOXIL (doxorubicin HCl liposome injection). Maximum duration of study participation for each participant will be 48 weeks.

Being tested
Thalidomide, Dexamethasone, DOXIL
Keywords
Multiple myeloma, Newly diagnosed multiple myeloma, Thalidomide, Dexamethasone, DOXIL, Pegylated liposomal hydrochloride doxorubicin injection
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThalidomideDrug

    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.

  • DexamethasoneDrug

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

  • DOXILDrug

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

Study groups in NCT00097981
Study groupRoleWhat they receive
Thalidomide + dexamethasoneActive comparatorNot described
Receives: Drug: Thalidomide; Drug: Dexamethasone
Thalidomide + dexamethasone + DOXILExperimentalNot described
Receives: Drug: Thalidomide; Drug: Dexamethasone; Drug: DOXIL

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From Cycle 2 until 28 days following completion of treatment

Secondary outcomes (6)

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

    Overall response to study medication is defined as number of participants who acheived a complete response (CR) or partial response (PR) 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; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.

    Measured: From Cycle 2 until 28 days following completion of treatment

  2. Time to 1st Response

    Time to first response was defined as the interval from date of randomization to date of achieving a partial response (PR) or better according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.

    Measured: From Cycle 2 until 28 days following completion of treatment

  3. Time to Progression

    Time to progression is the interval between the date of randomization until disease progression or death due to progression.

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

  4. Overall Survival: Number of Participants Died Due to Any Cause

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

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

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

  6. Engraftment: Number of Participants Who Underwent Engraftment

    Engraftment is the process of transplanted stem cells reproducing new cells.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2004 (estimated)
  2. Study startJan 2005
  3. Primary completionOct 2007
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00097981
Sponsor's protocol ID
CR004579
Other IDs
DO04-23-006
Status last verified
Feb 2017
First submitted
1 Dec 2004
Last updated
7 Apr 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Thalidomide, Dexamethasone and DOXIL in people with Multiple Myeloma, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 58 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2008). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response Rate: Number of Participants Who Achieved a Complete Response (time frame: From Cycle 2 until 28 days following completion of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00097981.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.

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