NCT00263484

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
Completed

Started Dec 2005

Typical duration for phase_2 multiple-myeloma

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

July 21, 2011

Status Verified

July 1, 2011

Enrollment Period

2.8 years

First QC Date

December 7, 2005

Last Update Submit

July 19, 2011

Conditions

Multiple Myeloma

Keywords

Steroids, FluorinatedThalidomideBisphosphonates

Outcome Measures

Primary Outcomes (1)

  • 1. To determine response rates (RR) and disease progression rates in all MM patients treated with dtZ regimen.

    4 months

Secondary Outcomes (3)

  • To assess overall survival (OS) in all patients treated with dtZ regimen.

    4 months

  • Assessment of incidence of skeletal related events (SREs).

    4 months

  • Assessment of percent change in renal function in all patients.

    4 months

Study Arms (1)

"dtZ" regimen, Initial therapy

EXPERIMENTAL

To test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma.

Drug: dexamethasoneDrug: thalidomideDrug: zoledronic acid

Interventions

dexamethasoneDRUG

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.

Also known as: DEXAMETHASONE BEACONS
"dtZ" regimen, Initial therapy
thalidomideDRUG

100 mg, PO (orally) on days 1-21 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.

Also known as: THALOMID (PHARMION), THADO (TTY)
"dtZ" regimen, Initial therapy
zoledronic acidDRUG

4 mg, IV (in the vein) on day 1 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.

Also known as: ZOMETA
"dtZ" regimen, Initial therapy

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Tata Memorial Hospital

Mumbai, Mumbai, 400 012, India

Location

Christian Medical College

Vellore, Tamil Nadu, 632004, India

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

National Cancer Centre, Singapore

Singapore, 169610, Singapore

Location

Gleneagles Hospital, Singapore

Singapore, 258500, Singapore

Location

Tan Tock Seng Hospital, Singapore

Singapore, 308433, Singapore

Location

Chonnam National University Hwasun Hospital

Gwangju, Gwangju, 519-809, South Korea

Location

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Samsung Medical Center, Seoul, South Korea

Seoul, Seoul, 135-710, South Korea

Location

ASAN Medical Center, University of Ulsan, South Korea

Seoul, Seoul, 138-736, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 11841428BACKGROUND

  • 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. doi: 10.1002/cncr.11701.

    PMID: 14534891BACKGROUND

  • 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. doi: 10.1200/JCO.2002.02.116.

    PMID: 12409330BACKGROUND

  • 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. doi: 10.1200/JCO.2003.03.139.

    PMID: 12506164BACKGROUND

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

DexamethasoneThalidomideZoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsImidazolesAzoles

Study Officials

  • Gerrard Teoh, MD

    Gleneagles Hospital, Singapore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2005

First Posted

December 8, 2005

Study Start

December 1, 2005

Primary Completion

October 1, 2008

Study Completion

October 1, 2010

Last Updated

July 21, 2011

Record last verified: 2011-07

Locations

IN(2)KR(4)SG(4)