Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma (dtZ)
This study has been completed.
Sponsor:
Gleneagles Hospital
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Drug Information available for:
Dexamethasone
Thalidomide
Dexamethasone acetate
Dexamethasone sodium phosphate
Zoledronic acid
U.S. FDA Resources
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:
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
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 | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of, 110-744 | |
| ASAN Medical Center, University of Ulsan, South Korea | |
| Seoul, Korea, Republic of, 138-736 | |
| Samsung Medical Center, Seoul, South Korea | |
| Seoul, Korea, Republic of, 135-710 | |
| Singapore | |
| Singapore General Hospital | |
| Singapore, Singapore, 169608 | |
| National Cancer Centre, Singapore | |
| Singapore, Singapore, 169610 | |
| Tan Tock Seng Hospital, Singapore | |
| Singapore, Singapore, 308433 | |
| Gleneagles Hospital, Singapore | |
| Singapore, Singapore, 258500 | |
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) |
| 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 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 Zoledronic acid Diphosphonates 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 May 23, 2013