Clinical trial NCT00097981: A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Multiple myeloma
Newly diagnosed multiple myeloma
Thalidomide
Dexamethasone
DOXIL
Pegylated liposomal hydrochloride doxorubicin injection
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
First posted: 2004-12-02
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Complete Response Rate: Number of Participants Who Achieved a Complete Response
timeFrame: From Cycle 2 until 28 days following completion of treatment
Secondary outcomes:
measure: Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)
timeFrame: From Cycle 2 until 28 days following completion of treatment
measure: Time to 1st Response
timeFrame: From Cycle 2 until 28 days following completion of treatment
measure: Time to Progression
timeFrame: From randomization until death or as assessed up to 2 years post last participant last treatment visit
measure: Overall Survival: Number of Participants Died Due to Any Cause
timeFrame: From randomization until death or as assessed up to 2 years post last participant last treatment visit
measure: Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow)
timeFrame: From randomization until death or as assessed up to 2 years post last participant last treatment visit
measure: Engraftment: Number of Participants Who Underwent Engraftment
timeFrame: From randomization until death or as assessed up to 2 years post last participant last treatment visit
Other outcomes:
Locations:
city: Fountain Valley
country: United States
state: California
city: Greenbrae
country: United States
state: California
city: La Verne
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: New London
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orange City
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Lawrenceville
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Bethesda
country: United States
state: Maryland
city: Minneapolis
country: United States
state: Minnesota
city: St Louis Park
country: United States
state: Minnesota
city: Columbia
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Englewood
country: United States
state: New Jersey
city: Hackensack
country: United States
state: New Jersey
city: Jersey City
country: United States
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Armonk
country: United States
state: New York
city: Box 302
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Nyack
country: United States
state: New York
city: Valhalla
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Wynnewood
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Easley
country: United States
state: South Carolina
city: Sumter
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Bedford
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Fredericksburg
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Fairfax
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
city: Yakima
country: United States
state: Washington
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: