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Early Response-adapted Intensification of Induction Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma (MM) Who Are Eligible for Autologous Stem Cell Transplantation: Multicenter Phase 2 Study


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

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Trial Information

Early Response-adapted Intensification of Induction Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma (MM) Who Are Eligible for Autologous Stem Cell Transplantation: Multicenter Phase 2 Study


This study aims to assess the efficacy and toxicities of CTD and Vel-CD induction followed
by high-dose therapy with autologous stem cell transplantation as a first line treatment for
the patients with multiple myeloma.The investigators already investigated the
thalidomide-based chemotherapy in patients with newly diagnosed MM. The combined regimen
consisted of cyclophosphamide, thalidomide and dexamethasone (CTD) for induction treatment.
CTD chemotherapy resulted in a favorable response with 79.4% overall response rate including
42.6% complete response (CR) or very good partial complete response (VGPR), and tolerable
toxicity in MM patients. Moreover, CTD chemotherapy did not affect the yield of the stem
cell collection.The investigators also published that the clinical efficacy and safety of a
four-drug combination of bortezomib, cyclophosphamide, thalidomide, and dexamethasone was
assessed for patients with relapsed or refractory multiple myeloma Vel-CTD chemotherapy.


Inclusion Criteria:



1. Newly diagnosed MM

2. Aged between 18 and 65 years old

3. With following measurable lesions (serum M-protein ≥ 1 g/dL or urine M-protein ≥ 400
mg/day, or free light chain ≥ 100 mg/L)

Exclusion Criteria:

1. Smoldering or indolent myeloma

2. ECOG performance status > 3 point

3. Known hypersensitivity to cyclophosphamide, 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, 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 clearance < 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:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate for induction chemotherapy

Outcome Time Frame:

2 years

Safety Issue:

Yes

Authority:

Korea: Institutional Review Board

Study ID:

KMM-97

NCT ID:

NCT01114048

Start Date:

March 2010

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • age under 65
  • Previous untreated
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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