Clinical Trial: Thal/Dex (Thalidomide and Dexamethasone) vs. Dd-T (Doxil, Dexamethasone and Thalidomide) in Multiple Myeloma Patients

This study is currently recruiting patients.

Sponsored by: Tibotec Therapeutics
Information provided by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Purpose

The primary purposes for this study is to compare the complete response (CR) rate in subjects with newly diagnosed Multiple Myeloma treated with thalidomide plus dexamethasone (Thal/Dex) versus DOXIL plus Dexamethasone and Thalidomide (Dd-T).

Condition Treatment or Intervention Phase
Multiple Myeloma
 Drug: Doxorubicin HCl liposome injection
 Drug: Dexamethasone
 Drug: Thalidomide
Phase III

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label

Official Title: A Randomized, Open-Label, Multi-Center Trial Comparing Thalidomide plus Dexamethasone (Thal/Dex) versus DOXIL® plus Dexamethasone and Thalidomide (Dd-T) in Subjects with Newly Diagnosed Multiple Myeloma

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Male or female at least 18 years of age
  • Previously untreated, histologically confirmed, symptomatic multiple myeloma as defined by International Myeloma Working Group
  • ECOG performance status 0-2
  • Previous radiation therapy for palliation of cord compression or pathologic fractures are permitted provided last dose is given 14 days prior to initiation of chemotherapy and does not involve the mediastinum
  • Subjects with radiographic evidence of lytic bone disease receiving concomitant bisphosphonate therapy may be enrolled
  • Adequate bone marrow (BM) function: *ANC ≥ 1,000/mm3 (if BM has > 50% plasma cells/mm3, then no specific minimum), *Platelet count >75,000 cells/mm3 (without transfusion support for 7 days prior to study entry) (if BM has >50% plasma cells/mm3, minimum platelet count >20,000 cells/mm3), *Hemoglobin ≥ 8.0 g/dL (without transfusion support for 7 days prior to study entry) (If BM has >50% plasma cells/mm3, then transfusion is allowed up to the time of enrollment to maintain Hbb > or = 7.0g/dL)
  • Corrected serum calcium <12 mg/dL (3.0 mmol/L). This level may be achieved by appropriate supportive care but it must be reached before the subject can be randomized
  • Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment
  • Willing and eligible to sign up for the S.T.E.P.S program, for subjects of childbearing potential
  • Negative pregnancy test, according to the S.T.E.P.S program, for subjects of childbearing potential
  • Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

  • Treated with more than two pulses of decadron within 2 weeks of randomization
  • Non-secretory disease (defined as no measurable paraprotein in serum or urine, urine paraprotein level < or = 200 mg/24 hours)
  • Peripheral neuropathy of Grade 2 or greater severity as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
  • Infection requiring intravenous antibiotic treatment
  • Inadequate renal function: *Creatinine > 4 mg/dL (> 200 mmol/L)
  • Inadequate liver function: *Bilirubin > 2 institutional upper limits of normal, *ALT and AST > 2.5X upper limit of normal
  • Life expectancy of less than 3 months
  • Pregnant or lactating subjects
  • No prior malignancy is allowed, except for adequately treated basal cell or squamous cell skin cancer, or cervical cancer in-situ, or other cancer from which the subject has been disease-free for at least 3 years
  • Solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
  • History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCl, or the components of DOXIL, vincristine, dexamethasone or thalidomide
  • Multiple gated acquisition (MUGA) showing the LVEF less than 45%
  • History of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure
  • History of deep venous thrombosis (DVT)
  • Myocardial infarction within 6 months before enrollment in the study
  • Uncontrolled medical problems such as diabetes mellitus, cardiac (i.e. congestive heart failure, coronary artery disease, arrhythmias), pulmonary, hepatic, and renal diseases unless renal insufficiency is felt by the investigator to be secondary to multiple myeloma
  • Major surgery within 4 weeks before randomization
  • Psychiatric or central nervous system disorders interfering with compliance of orally administered medication
  • Experimental drug or experimental regimen within 4 weeks before randomization
  • Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator

Location and Contact Information


California
      Pacific Cancer Medical Center, Anaheim,  California,  92801,  United States; Recruiting
Brenda Cornejo  714-999-1465 
Veena Charu, MD,  Principal Investigator

      Lalita Pandit, MD, Inc, Fountain Valley,  California,  92708,  United States; Recruiting
Veronica Aguilar  714-432-9200 
Lalita Pandit, MD,  Principal Investigator

Connecticut
      Oncology and Hematology Associates, New London,  Connecticut,  06320,  United States; Recruiting
Steffany Willert  860-439-1770 
Richard Hellman, MD,  Principal Investigator

Florida
      Osceola Cancer Center, Kissimee,  Florida,  34741,  United States; Recruiting
Donna Bradley  401-933-2775 
Jorge Otoya, MD,  Principal Investigator

      Metcare Oncology, Ormond Beach,  Florida,  32174,  United States; Recruiting
Mitchell Weisberg, MD  386-615-1056 
Mitchell Weisberg, MD,  Principal Investigator

      Center for Hematology Oncology, Boca Raton,  Florida,  33486,  United States; Recruiting
Delores Preiser  561-416-8869  Ext. 262 
Deborah Zipin, MD,  Principal Investigator

Georgia
      Suburban Hematology & Oncology, Lawrenceville,  Georgia,  30045,  United States; Recruiting
Kathy Frank  678-533-1587 
Anthony Landis, MD,  Principal Investigator

Minnesota
      Park Nicollet Institute, St. Louis Park,  Minnesota,  55416,  United States; Recruiting
Brad Farrell  952-993-2754 
Martin Lee, MD,  Principal Investigator

      Hubert Humphrey Cancer Center, Robbinsdale,  Minnesota,  55422,  United States; Recruiting
Nancy Sundeen, RN  763-520-5847 
Martin Oken, MD,  Principal Investigator

New York
      Advanced Oncology Associates, Armonk,  New York,  10504,  United States; Recruiting
Connie Brickson  914-273-2977 
Bernard Bernhardt, MD,  Principal Investigator

      Union State Bank Cancer Center, Nyack,  New York,  10960,  United States; Recruiting
Sandra Narin  845-348-8507 
Brad Cohen, MD,  Principal Investigator

South Carolina
      South Carolina Oncology Associates, Columbia,  South Carolina,  29210,  United States; Recruiting
Jennifer Peelman  803-461-3095 
Rosemary Lambert Falls, MD,  Principal Investigator

      Santee Hematology/Oncology, Sumter,  South Carolina,  29150,  United States; Recruiting
Wei Chang  803-934-8833 
Billy W Clowney, MD,  Principal Investigator

Virginia
      Virgina Cancer Institute, Richmond,  Virginia,  23230,  United States; Recruiting
Sabina Hatchell  804-281-0965 
Joseph Evers, MD,  Principal Investigator

More Information

Study ID Numbers:  DO04-23-006
Record last reviewed:  February 2005
Last Updated:  February 14, 2005
Record first received:  December 1, 2004
ClinicalTrials.gov Identifier:  NCT00097981
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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