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

This study has been completed.
Sponsor:
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00097981
First received: December 1, 2004
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Thalidomide
Drug: Dexamethasone
Drug: DOXIL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Complete Response Rate: Number of Participants Who Achieved a Complete Response [ Time Frame: From Cycle 2 until 28 days following completion of treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) [ Time Frame: From Cycle 2 until 28 days following completion of treatment ] [ Designated as safety issue: No ]
    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.

  • Time to 1st Response [ Time Frame: From Cycle 2 until 28 days following completion of treatment ] [ Designated as safety issue: No ]
    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.

  • Time to Progression [ Time Frame: From randomization until death or as assessed up to 2 years post last participant last treatment visit ] [ Designated as safety issue: No ]
    Time to progression is the interval between the date of randomization until disease progression or death due to progression.

  • Overall Survival: Number of Participants Died Due to Any Cause [ Time Frame: From randomization until death or as assessed up to 2 years post last participant last treatment visit ] [ Designated as safety issue: No ]
  • Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow) [ Time Frame: From randomization until death or as assessed up to 2 years post last participant last treatment visit ] [ Designated as safety issue: No ]
  • Engraftment: Number of Participants Who Underwent Engraftment [ Time Frame: From randomization until death or as assessed up to 2 years post last participant last treatment visit ] [ Designated as safety issue: No ]
    Engraftment is the process of transplanted stem cells reproducing new cells.


Enrollment: 225
Study Start Date: January 2005
Study Completion Date: October 2009
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Thalidomide + dexamethasone Drug: Thalidomide
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.
Drug: Dexamethasone
Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20.
Experimental: Thalidomide + dexamethasone + DOXIL Drug: Thalidomide
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.
Drug: Dexamethasone
Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20.
Drug: DOXIL
DOXIL 40 mg/m2 will be administered iintravenously (into a vein) on Day 1.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097981

  Show 58 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00097981     History of Changes
Other Study ID Numbers: CR004579, DO04-23-006
Study First Received: December 1, 2004
Results First Received: October 2, 2008
Last Updated: September 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Multiple myeloma
Newly diagnosed multiple myeloma
Thalidomide
Dexamethasone
DOXIL
Pegylated liposomal hydrochloride doxorubicin injection

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Liposomal doxorubicin
Thalidomide
Doxorubicin
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 22, 2014