A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00057564
First received: April 4, 2003
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma


Condition Intervention Phase
Multiple Myeloma
Drug: A (Thalidomide + Dexamethasone)
Drug: B (Placebo + Dexamethasone)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Parallel-group , Double Blind, Placebo-controlled Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Time to tumor progression (TTP) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Time to tumor progression (TTP)


Secondary Outcome Measures:
  • Number of patients who survived [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Number of patients who survived

  • Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)

  • Myeloma response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Myeloma response determination criteria developed by Bladé et al 1998

  • Number of participants with adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events


Enrollment: 470
Study Start Date: February 2003
Estimated Study Completion Date: December 2014
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A (Thalidomide & Dexamethasone)
Thalidomide 50mg/day + Dexamethasone 40mg
Drug: A (Thalidomide + Dexamethasone)
Thalidomide 50mg/day + Dexamethasone 40mg
Other Name: Thalidomide
Placebo Comparator: B (Dexamethasone and placebo)
Dexamethasone and placebo
Drug: B (Placebo + Dexamethasone)
Placebo + Dexamethasone 40mg
Other Names:
  • Dexamethasone
  • placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active Multiple Myeloma Stage II or III Durie Salmon
  • Measurable levels of myeloma paraprotein in serum (≥1.0g/dL) or urine (≥ 0.2g excreted in a 24-hour collection sample)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
  • Women of child bearing potential must agree to abstain for heterosexual intercourse or use 2 methods of contraception, one effective (for example hormonal or tubal ligation) and one barrier (for example latex condom, diaphragm)
  • Males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity

Exclusion Criteria:

  • Pregnant or lactating females
  • Peripheral neuropathy ≥ to grade 2 of the NCI CTC.
  • Prior history of malignancy unless subject has been free of disease for ≥ 3 years
  • Lab abnormality: Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L)
  • Lab abnormality: Platelet count <50,000/mm^3 (50.0 x 10^9/L)
  • Lab abnormality: Serum creatinine >3.0 mg/dL (265 µmol/L)
  • Lab abnormality: Serum glutamic oxaloacetic transaminase (SGOT) /Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine transaminase (ALT) >3.0 x upper limit of normal (ULN)
  • Lab abnormality: Serum total bilirubin > 2.0 mg/dL (34 µmol/L)
  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: NCT00057564

  Show 99 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Robert Knight, MD Celgene Corporation
  More Information

Publications:
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00057564     History of Changes
Other Study ID Numbers: THAL-MM-003
Study First Received: April 4, 2003
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Newly Diagnosed Multiple Myeloma
Multiple Myeloma

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
Thalidomide
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
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on September 18, 2014