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

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00263484
First received: December 7, 2005
Last updated: July 19, 2011
Last verified: July 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess overall survival (OS) in all patients treated with dtZ regimen. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Assessment of incidence of skeletal related events (SREs). [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Assessment of percent change in renal function in all patients. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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: 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
ASAN Medical Center, University of Ulsan, South Korea
Seoul, Korea, Republic of, 138-736
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Samsung Medical Center, Seoul, South Korea
Seoul, Korea, Republic of, 135-710
Singapore
Gleneagles Hospital, Singapore
Singapore, Singapore, 258500
Singapore General Hospital
Singapore, Singapore, 169608
Tan Tock Seng Hospital, Singapore
Singapore, Singapore, 308433
National Cancer Centre, Singapore
Singapore, Singapore, 169610
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

Publications:
Responsible Party: Dr Gerrard Teoh, Gleneagles Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00263484     History of Changes
Other Study ID Numbers: SQMM01(dtZ)
Study First Received: December 7, 2005
Last Updated: July 19, 2011
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Gleneagles Hospital:
Steroids, Fluorinated
Thalidomide
Bisphosphonates

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Thalidomide
Zoledronic acid
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 23, 2014