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Induction Therapy With TCD Regimen (Thalidomide, Cyclophosphamide, Dexamethasone) Followed by Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

Induction Therapy With TCD Regimen (Thalidomide, Cyclophosphamide, Dexamethasone) Followed by Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients


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.


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.

15. Receipt of extensive radiation therapy within 4 weeks

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate of TCD induction Therapy

Principal Investigator

Je-Jung Lee, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chonnam National University Hospital

Authority:

Singapore: Domain Specific Review Boards

Study ID:

KMM53

NCT ID:

NCT00349115

Start Date:

June 2006

Completion Date:

June 2008

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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