Multiple MyelomaPhase 2dtZNCT00263484
Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma
A Phase 2 study testing dexamethasone, thalidomide and zoledronic acid in people with Multiple Myeloma, run by Gleneagles Hospital at 10 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- dexamethasone, thalidomide and zoledronic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Dec 2005to Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Singapore4 sites
Singapore General Hospital
Singapore, 169608
National Cancer Centre, Singapore
Singapore, 169610
Gleneagles Hospital, Singapore
Singapore, 258500
Tan Tock Seng Hospital, Singapore
Singapore, 308433
South Korea4 sites
Chonnam National University Hwasun Hospital
Gwangju, Gwangju, 519-809
Seoul National University Hospital
Seoul, Seoul, 110-744
Samsung Medical Center, Seoul, South Korea
Seoul, Seoul, 135-710
ASAN Medical Center, University of Ulsan, South Korea
Seoul, Seoul, 138-736
India2 sites
Tata Memorial Hospital
Mumbai, Mumbai, 400 012
Christian Medical College
Vellore, Tamil Nadu, 632004
About this 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
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- dexamethasone, thalidomide, zoledronic acid
- Keywords
- Steroids, Fluorinated, Thalidomide, Bisphosphonates
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
Also called DEXAMETHASONE BEACONS
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.
thalidomideDrug
Also called THALOMID (PHARMION), THADO (TTY)
100 mg, PO (orally) on days 1-21 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
zoledronic acidDrug
Also called ZOMETA
4 mg, IV (in the vein) on day 1 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| "dtZ" regimen, Initial therapy | Experimental | To test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma. Receives: Drug: dexamethasone; Drug: thalidomide; Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. To determine response rates (RR) and disease progression rates in all MM patients treated with dtZ regimen.
Measured: 4 months
Secondary outcomes (3)
To assess overall survival (OS) in all patients treated with dtZ regimen.
Measured: 4 months
Assessment of incidence of skeletal related events (SREs).
Measured: 4 months
Assessment of percent change in renal function in all patients.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionOct 2008
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gleneagles Hospital
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Gerrard Teoh, MD, Study chair, Gleneagles Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263484
- Sponsor's protocol ID
- SQMM01(dtZ)
- Acronym
- dtZ
- Status last verified
- Jul 2011
- First submitted
- 7 Dec 2005
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1046/j.1365-2141.2002.03257.x.
PubMed 11841428Rosen 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. doi: 10.1002/cncr.11701.
PubMed 14534891Rajkumar 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. doi: 10.1200/JCO.2002.02.116.
PubMed 12409330Weber 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. doi: 10.1200/JCO.2003.03.139.
PubMed 12506164
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00263484
- Acronym / sponsor ID
- dtZ / SQMM01(dtZ)
- Conditions
- Multiple Myeloma
- Keywords
- Steroids, Fluorinated, Thalidomide, Bisphosphonates
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Gleneagles HospitalUniversity, hospital or other
- 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
- Study start
- Dec 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "dtZ" regimen, Initial therapy | Experimental | Drug: dexamethasone, Drug: thalidomide, Drug: zoledronic acidTo test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasoneAlso: DEXAMETHASONE BEACONS20 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. | Drug | "dtZ" regimen, Initial therapy |
| thalidomideAlso: THALOMID (PHARMION), THADO (TTY)100 mg, PO (orally) on days 1-21 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops. | Drug | "dtZ" regimen, Initial therapy |
| zoledronic acidAlso: ZOMETA4 mg, IV (in the vein) on day 1 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops. | Drug | "dtZ" regimen, Initial therapy |
Primary outcome
1. To determine response rates (RR) and disease progression rates in all MM patients treated with dtZ regimen.
Time frame: 4 months
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
- Background: PubMed 11841428Yaccoby 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. doi: 10.1046/j.1365-2141.2002.03257.x.
- Background: PubMed 14534891Rosen 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. doi: 10.1002/cncr.11701.
- Background: PubMed 12409330Rajkumar 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. doi: 10.1200/JCO.2002.02.116.
- Background: PubMed 12506164Weber 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. doi: 10.1200/JCO.2003.03.139.
- Clinic for Blood Disorders and Research (CBD), Gleneagles Hospital, SingaporeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerrard Teoh, MD study chair
Gleneagles Hospital, Singapore
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dexamethasone, thalidomide and zoledronic acid in people with Multiple Myeloma, run by Gleneagles Hospital at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Singapore, South Korea, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. To determine response rates (RR) and disease progression rates in all MM patients treated with dtZ regimen. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00263484, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2011.