We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma (dtZ)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00263484
First Posted: December 8, 2005
Last Update Posted: July 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Singapore General Hospital
National Cancer Centre, Singapore
Tan Tock Seng Hospital
Seoul National University Hospital
Asan Medical Center
Samsung Medical Center
Chonnam National University Hospital
Christian Medical College, Vellore, India
Tata Memorial Hospital
Information provided by:
Gleneagles Hospital
  Purpose
The purpose of this study is to determine whether lower than conventional doses of dexamethasone and thalidomide; and a higher dosing frequency of zoledronic acid are effective in the treatment of newly-diagnosed multiple myeloma.

Condition Intervention Phase
Multiple Myeloma Drug: dexamethasone Drug: thalidomide Drug: zoledronic acid Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An International, Multicenter, Non-Randomized, Open-Labeled Study to Evaluate the Efficacy of Lower Dose Dexamethasone/Thalidomide and Higher Frequency ZOMETA(TM) in the Treatment of Previously Untreated Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Gleneagles Hospital:

Primary Outcome Measures:
  • 1. To determine response rates (RR) and disease progression rates in all MM patients treated with dtZ regimen. [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • To assess overall survival (OS) in all patients treated with dtZ regimen. [ Time Frame: 4 months ]
  • Assessment of incidence of skeletal related events (SREs). [ Time Frame: 4 months ]
  • Assessment of percent change in renal function in all patients. [ Time Frame: 4 months ]

Enrollment: 56
Study Start Date: December 2005
Study Completion Date: October 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: "dtZ" regimen, Initial therapy
To test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma.
Drug: dexamethasone
20 mg, PO (orally) on days 1-4, 8-11 and 15-18 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
Other Name: DEXAMETHASONE BEACONS
Drug: thalidomide
100 mg, PO (orally) on days 1-21 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
Other Names:
  • THALOMID (PHARMION)
  • THADO (TTY)
Drug: zoledronic acid
4 mg, IV (in the vein) on day 1 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
Other Name: ZOMETA

Detailed Description:
Patients with newly-diagnosed multiple myeloma (MM) may be treated using monthly cycles of dexamethasone plus thalidomide (DT). Unfortunately, the use of conventional doses of DT is associated with significant treatment-related morbidity and mortality, which is comparable to that observed with conventional chemotherapy. Hence, for safety reasons, patients frequently receive lower than conventional doses of DT (i.e. dt), and potentially experience a poorer anti-MM effect. The highly-potent aminobisphosphonate, zoledronic acid (Z), has been shown in pre-clinical mouse models to exhibit an impressive anti-MM effect. It is therefore possible to combined dt with Z (i.e. dtZ) to enhance the efficacy of (lower dose) dt. In addition, the anti-tumor effect of dtZ may potentially be augmented by using Z at a higher (three-weekly) dosing frequency.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at or above 21 years
  • Clinical diagnosis of MM
  • Active MM with measurable disease
  • Signed written informed consent
  • Signed consent for drug safety program for thalidomide

Exclusion Criteria:

  • Patients with Monoclonal Gammopathy of Undetermined Significance (MGUS)
  • Patients with Indolent MM (IMM), or Smouldering MM (SMM)
  • Known hypersensitivity (including severe cutaneous reactions) to d, t or Z
  • Fulminant sepsis
  • Females in the reproductive age group who refuse contraception
  • Pregnancy
  • 24 hr urinary creatinine clearance time (CCT) <30 ml/min
  • Previous renal transplantation
  • Severe peripheral neuropathy
  • Recurrent DVT or PE
  • Severe arrhythmias and cardiac conduction disorders
  • Liver dysfunction of active viral hepatitis
  • Osteonecrosis of the jaws (ONJ)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263484


Locations
India
Christian Medical College
Vellore, Tamil Nadu, India, 632004
Tata Memorial Hospital
Mumbai, India, 400 012
Korea, Republic of
Chonnam National University Hwasun Hospital
Kwangju, Korea, Republic of, 519-809
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Samsung Medical Center, Seoul, South Korea
Seoul, Korea, Republic of, 135-710
ASAN Medical Center, University of Ulsan, South Korea
Seoul, Korea, Republic of, 138-736
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
National Cancer Centre, Singapore
Singapore, Singapore, 169610
Gleneagles Hospital, Singapore
Singapore, Singapore, 258500
Tan Tock Seng Hospital, Singapore
Singapore, Singapore, 308433
Sponsors and Collaborators
Gleneagles Hospital
Singapore General Hospital
National Cancer Centre, Singapore
Tan Tock Seng Hospital
Seoul National University Hospital
Asan Medical Center
Samsung Medical Center
Chonnam National University Hospital
Christian Medical College, Vellore, India
Tata Memorial Hospital
Investigators
Study Chair: Gerrard Teoh, MD Gleneagles Hospital, Singapore
  More Information

Additional Information:
Publications:
Responsible Party: Dr Gerrard Teoh, Gleneagles Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00263484     History of Changes
Other Study ID Numbers: SQMM01(dtZ)
First Submitted: December 7, 2005
First Posted: December 8, 2005
Last Update Posted: July 21, 2011
Last Verified: July 2011

Keywords provided by Gleneagles Hospital:
Steroids, Fluorinated
Thalidomide
Bisphosphonates

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
Thalidomide
BB 1101
Zoledronic acid
Diphosphonates
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal