CClinicalTrials.gg
Status unknownNCT00349115Updated May 6, 2008

TCD Followed by autoSCT for Newly Diagnosed MM Patients

A Phase 2 interventional study of Thalidomide in Multiple Myeloma, sponsored by Korean Multiple Myeloma Working Party. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-05-06.

Sponsored by Korean Multiple Myeloma Working Party · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
43
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Multiple Myeloma is a incurable disease. Thalidomide in combination with other agents are currently in trials for the newly diagnosed patients, we designed treatment of TCD, followed by high dose chemotherapy with autologous stem cell transplantation and TD maintenance therapy for the patients with newly diagnosed multiple myeloma.

Read the detailed description

Phase II clinical trial for the patients with newly diagnosed. TCD (thalidomide, cyclophosphamide and dexamethasone) will be applied for the patients as an induction chemotherapy, followed by high dose chemotherpy and autologous stem cell transplantation. Afterthen, they will receive TD (thalidomide and dexamethasone) maintenance therapy for one year.

02

Conditions studied

03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 43 is close to the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Korean Multiple Myeloma Working Party is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:Newly diagnosed multiple myeloma in aged between 18 and 75 years old with following mesurable leisons: (serum M-protein ≥ 1 g/dL or urine M-protein ≥ 400 mg/day) -

Exclusion Criteria:

    1. Smoldering or indolent myeloma 2. ECOG performance status > 3 point 3. Known hypersensitivity to cyclphosphamide, thalidomide or dexamethasone 4. Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3 5. Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, cardiac ejection fraction \<0.5 : Severe conduction disorder : Hypotension (sitting systolic BP ≤ 100 mmHg and/or sitting diastolic BP ≤ 60 mmHg 6. Impaired hepatic function (AST or ALT ≥ x 3 upper normal, T-bilirubin ≥ x 2 upper normal) 7. Creatinine cliearance \< 20 ml/min 8. Corrected serum calcium ≥ 14 mg/dL 9. Sepsis or current active infection 10. Pregnancy or breast feeding 11. Uncontrolled Diabetes Mellitus 12. Previous history of Recurrent DVT or pulmonary embolism 13. Active ulcers detected by gastroscopy 14. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  1. Receipt of extensive radiation therapy within 4 weeks
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (estimated)

Interventions

  • DrugThalidomide
06

What researchers measure

Primary outcomes

  1. Response rate of TCD induction Therapy

Secondary outcomes

  1. Progression free survival and Overall survival of TCD, followed by high dose chemotherapy and autoPBSCT and TD maintenance

  2. To evaluate toxicities of TCD, followed by high dose chemotherapy and autoPBSCT and TD maintenance.

07

Study locations

1 of 1 sites recruiting
  • Je-Jung Lee
    Hwsun-eup, Hwasun-gun, Jeollanam-do 519-809, Korea, Republic of
    • Yeo-Kyeoung Kim, MD, PhD · Contact · yeokim@chonnam.ac.kr · 82-61-379-7639
    • Je-Jung Lee, MD, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00349115
Lead sponsor
Korean Multiple Myeloma Working Party
Collaborators
Celgene Corporation
First posted
Jul 6, 2006
Start date
Jun 2006
Completion
Jun 2008 (estimated)
Last update
May 6, 2008

Study contacts

Je-Jung Lee, MD, PhD
Contact
yeokim@chonnam.ac.kr
82-61-379-7639
Yeo-Kyeoung Kim, MD, PhD
Contact
yeokim@chonnam.ac.kr
82-61-379-7639
Je-Jung Lee, MD, PhD
principal investigator · Chonnam National University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.

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