Not Signed In -
Azelaic Acid Topical |
Azelex; Finacea; Finevin |
Clinical Trial: Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma
This study is not yet open for patient recruitment.
Verified by Singapore General Hospital December 2005
|
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 II |
MedlinePlus related topics: Multiple Myeloma
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
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
Further study details as provided by Singapore General Hospital:
Primary Outcomes: 1. To determine response rates (RR) and disease progression rates in all MM patients treated with dtZ regimen at 4 months.
Secondary Outcomes: 1. To assess overall survival (OS) in all patients treated with dtZ regimen at 4 months.; 2. Assessment of incidence of skeletal related events (SREs) over 4 months.; 3. Assessment of percent change in renal function in all patients over 4 months.; 4. Assessment of change in number of bone marrow (BM) CD34-positive stem cells in all patients over 4 months.; 5. Assessment of change in gene expression profile over 4 months.
Expected Total Enrollment: 50
Secondary Outcomes: 1. To assess overall survival (OS) in all patients treated with dtZ regimen at 4 months.; 2. Assessment of incidence of skeletal related events (SREs) over 4 months.; 3. Assessment of percent change in renal function in all patients over 4 months.; 4. Assessment of change in number of bone marrow (BM) CD34-positive stem cells in all patients over 4 months.; 5. Assessment of change in gene expression profile over 4 months.
Expected Total Enrollment: 50
Study start: December 2005; Expected completion: May 2007
Last follow-up: November 2006; Data entry closure: February 2007
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 above, Genders Eligible for Study: Both
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
- Serum creatinine (Cr) >248 μmol/L or >2.8 mg/dL
- 24 hr urinary creatinine clearance time (CCT) <60 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)
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00263484
Gerrard Teoh, MD 65-6321-3948 ghetkh@sgh.com.sg
Daryl Tan, MD 65-6321-4855 daryl.tan@singhealth.com.sg
Daryl Tan, MD 65-6321-4855 daryl.tan@singhealth.com.sg
India
Tata Memorial Hospital, Mumbai, 400 012, India
Purvish M Parikh, MD PhD 91-22-2414-6937 purvish@rediffmail.com
Vasant R Pai, MD 91-22-2417-7204 drvrpai@rediffmail.com
Purvish M Parikh, MD PhD, Principal Investigator
Vasant R Pai, MD, Sub-Investigator
Vasant R Pai, MD 91-22-2417-7204 drvrpai@rediffmail.com
Purvish M Parikh, MD PhD, Principal Investigator
Vasant R Pai, MD, Sub-Investigator
India, Tamil Nadu
Christian Medical College, Vellore, Tamil Nadu, 632004, India
Alok Srivastava, MD PhD 91-416-228- aloks@cmcvellore.ac.in
Vikram Mathews, MD DM 91-416-228-2891 vikram@cmcvellore.ac.in
Alok Srivastava, MD FRCP, Principal Investigator
Vikram Mathews, MD DM, Sub-Investigator
Auro Viwabandya, MD DM, Sub-Investigator
Vikram Mathews, MD DM 91-416-228-2891 vikram@cmcvellore.ac.in
Alok Srivastava, MD FRCP, Principal Investigator
Vikram Mathews, MD DM, Sub-Investigator
Auro Viwabandya, MD DM, Sub-Investigator
Korea, Republic of
Chonnam National University Hwasun Hospital, Kwangju, 519-809, Korea, Republic of
Je Jung Lee, MD PhD 82-61-379-7638 drjejung@chonnam.ac.kr
Hyeong Joon Kim, MD PhD 82-61-379-7637 hjoonk@chonnam.ar.kr
Je Jung Lee, MD PhD, Principal Investigator
Hyeong Joon Kim, MD PhD, Sub-Investigator
Hyeong Joon Kim, MD PhD 82-61-379-7637 hjoonk@chonnam.ar.kr
Je Jung Lee, MD PhD, Principal Investigator
Hyeong Joon Kim, MD PhD, Sub-Investigator
Seoul National University Hospital, Seoul, 110-744, Korea, Republic of
Sung Soo Yoon, MD PhD 82-2-2072-3079 ssysmc@snu.ac.kr
In Ho Kim, MD PhD 82-2-2072-0834 kim_dajung@hanmail.net
Sung Soo Yoon, MD PhD, Principal Investigator
In Ho Kim, MD PhD, Sub-Investigator
Seon Yang Park, MD PhD, Sub-Investigator
Byoung Kook Kim, MD PhD, Sub-Investigator
In Ho Kim, MD PhD 82-2-2072-0834 kim_dajung@hanmail.net
Sung Soo Yoon, MD PhD, Principal Investigator
In Ho Kim, MD PhD, Sub-Investigator
Seon Yang Park, MD PhD, Sub-Investigator
Byoung Kook Kim, MD PhD, Sub-Investigator
ASAN Medical Center, University of Ulsan, South Korea, Seoul, 138-736, Korea, Republic of
Cheol Won Suh, MD PhD 82-2-3010-3209 csuh@amc.seoul.kr
Sung Bae Kim, MD PhD 82-2-3010-3217 sbkim3@amc.seoul.kr
Cheol Won Suh, MD PhD, Principal Investigator
Sung Bae Kim, MD PhD, Sub-Investigator
Sung Bae Kim, MD PhD 82-2-3010-3217 sbkim3@amc.seoul.kr
Cheol Won Suh, MD PhD, Principal Investigator
Sung Bae Kim, MD PhD, Sub-Investigator
Samsung Medical Center, Seoul, South Korea, Seoul, 135-710, Korea, Republic of
Ki Hyun Kim, MD PhD 82-2-3410-3456 kihyunk@smc.samsung.co.kr
Chul Won Jung, MD PhD 82-2-3410-3452 leukemia@smc.samsung.co.kr
Ki Hyun Kim, MD PhD, Principal Investigator
Chul Won Jung, MD PhD, Sub-Investigator
Jin Seok Ahn, MD PhD, Sub-Investigator
Chul Won Jung, MD PhD 82-2-3410-3452 leukemia@smc.samsung.co.kr
Ki Hyun Kim, MD PhD, Principal Investigator
Chul Won Jung, MD PhD, Sub-Investigator
Jin Seok Ahn, MD PhD, Sub-Investigator
Malaysia
Gleneagles Medical Centre (Penang), Malaysia, Penang, 10500, Malaysia
Kin Wah Leong, MD 604 - 227-6111 leongncl@tm.net.my
Kin Wah Leong, MD, Principal Investigator
Kin Wah Leong, MD, Principal Investigator
Singapore
Singapore General Hospital, Singapore, 169608, Singapore
Gerrard Teoh, MD 65-6321-3948 ghetkh@sgh.com.sg
Daryl Tan, MD 65-6321-4855 daryl.tan@singhealth.com.sg
Gerrard Teoh, MD, Principal Investigator
Daryl Tan, MD, Principal Investigator
William Hwang, MD, Sub-Investigator
Liang Piu Koh, MD, Sub-Investigator
Mickey Koh, MD, Sub-Investigator
Sim Leng Tien, MD, Sub-Investigator
Gee Chuan Wong, MD, Sub-Investigator
Charles Chuah, MD, Sub-Investigator
Heng Joo Ng, MD, Sub-Investigator
Yvonne Loh, MD, Sub-Investigator
Richard Yiu, MD, Sub-Investigator
Grace Kam, MD, Sub-Investigator
Daryl Tan, MD 65-6321-4855 daryl.tan@singhealth.com.sg
Gerrard Teoh, MD, Principal Investigator
Daryl Tan, MD, Principal Investigator
William Hwang, MD, Sub-Investigator
Liang Piu Koh, MD, Sub-Investigator
Mickey Koh, MD, Sub-Investigator
Sim Leng Tien, MD, Sub-Investigator
Gee Chuan Wong, MD, Sub-Investigator
Charles Chuah, MD, Sub-Investigator
Heng Joo Ng, MD, Sub-Investigator
Yvonne Loh, MD, Sub-Investigator
Richard Yiu, MD, Sub-Investigator
Grace Kam, MD, Sub-Investigator
National Cancer Centre, Singapore, Singapore, 169610, Singapore
Sandeep K Rajan, MD 65-6436-8169 dmoskr@nccs.com.sg
Miriam Tao, MD 65-6436-8167 dmomit@nccs.com.sg
Sandeep K Rajan, MD, Principal Investigator
Miriam Tao, MD, Sub-Investigator
Soon Thye Lim, MD, Sub-Investigator
Miriam Tao, MD 65-6436-8167 dmomit@nccs.com.sg
Sandeep K Rajan, MD, Principal Investigator
Miriam Tao, MD, Sub-Investigator
Soon Thye Lim, MD, Sub-Investigator
Tan Tock Seng Hospital, Singapore, Singapore, 308433, Singapore
Ponnudurai Kuperan, MD 65-6357-8926 ponnudurai_kuperan@ttsh.com.sg
Ponnudurai Kuperan, MD, Principal Investigator
Ponnudurai Kuperan, MD, Principal Investigator
Study chairs or principal investigators
Gerrard Teoh, MD, Study Chair, Singapore General Hospital
More Information
Publications
Yaccoby S, Pearse RN, Johnson CL, Barlogie B, Choi Y, Epstein J. Myeloma interacts with the bone marrow microenvironment to induce osteoclastogenesis and is dependent on osteoclast activity. Br J Haematol. 2002 Feb;116(2):278-90.
Rosen LS, Gordon D, Kaminski M, Howell A, Belch A, Mackey J, Apffelstaedt J, Hussein MA, Coleman RE, Reitsma DJ, Chen BL, Seaman JJ. Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial. Cancer. 2003 Oct 15;98(8):1735-44.
Rajkumar SV, Hayman S, Gertz MA, Dispenzieri A, Lacy MQ, Greipp PR, Geyer S, Iturria N, Fonseca R, Lust JA, Kyle RA, Witzig TE. Combination therapy with thalidomide plus dexamethasone for newly diagnosed myeloma. J Clin Oncol. 2002 Nov 1;20(21):4319-23.
Weber D, Rankin K, Gavino M, Delasalle K, Alexanian R. Thalidomide alone or with dexamethasone for previously untreated multiple myeloma. J Clin Oncol. 2003 Jan 1;21(1):16-9.
Study ID Numbers: SQMM01(dtZ)
Last Updated: December 8, 2005
Record first received: December 7, 2005
ClinicalTrials.gov Identifier: NCT00263484
Health Authority: Singapore: Health Sciences Authority
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 8, 2005
Record first received: December 7, 2005
ClinicalTrials.gov Identifier: NCT00263484
Health Authority: Singapore: Health Sciences Authority
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- Azelaic Acid Topical (Drug Digest)
- Azelex (Drug Digest)
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