UnknownPhase 2

Early Response-adapted Intensification of Induction Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma (MM)

South Korea78 participantsStarted 2010-03

Plain-language summary

In this study, the investigators will analyze the long-term outcomes of remission and survival, and identify those with primary resistant disease as more likely to benefit from CTD (thalidomide, cyclophosphamide, dexamethasone) and early intensification of Vel-CD (bortezomib and CD) as induction chemotherapy followed by autologous stem cell transplantation for the patients with newly diagnosed multiple myeloma.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Newly diagnosed MM
✓. Aged between 18 and 65 years old
✓. 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

✕. Smoldering or indolent myeloma
✕. ECOG performance status \> 3 point
✕. Known hypersensitivity to cyclophosphamide, thalidomide or dexamethasone
✕. Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3
✕. 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
✕. Impaired hepatic function (AST or ALT ≥ x 3 upper normal, T-bilirubin ≥ x 2 upper normal)
✕. Creatinine clearance \< 20 ml/min
✕. Corrected serum calcium ≥ 14 mg/dL

What they're measuring

response rate for induction chemotherapy

Timeframe: 2 years

Trial details

NCT IDNCT01114048

SponsorChonnam National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-03

Contact for this trial

Je-Jung Lee, M.D. and Ph.D.

82-61-3797638 drjejung@chonnam.ac.kr

View on ClinicalTrials.gov More Multiple Myeloma trials