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

NCT01114048 | Unknown Phase 2 DMC

• 1 other identifier: KMM-97
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Keywords

age under 65; Previous untreated

Outcome Measures

Primary Outcomes (1)

• response rate for induction chemotherapy

  2 years

Interventions

Thalidomide, cyclophosphamide, dexamethasone, bortezomib DRUG

1. Induction therapy with CTD regimen for 4 cycles Thalidomide 50-100 mg P.O. HS D 1\~28 Cyclophosphamide 150 mg/m² P.O. D 1\~4 Dexamethasone 20 mg/ m² IV or P.O. D 1\~4, 15-18 Repeated every 28 days 2. Intensification with Vel-CD regimen for 4 cycles (patients who fail to achieve more than PR after 2 cycles of CTD) Velcade 1.3 mg/m2 IV D1, 4, 8, 11 Cyclophosphamide 150 mg/m² P.O. D 1\~4 Dexamethasone 20 mg/ m² IV or P.O. D1, 4, 8, 11 Repeated every 21 days * Bactrim prophylaxis during dexamethasone administration Acyclovir prophylaxis during velcade administration Aspirin medication during thalidomide administration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Sepsis or current active infection
• Pregnancy or breast feeding
• Uncontrolled Diabetes Mellitus
• Previous history of Recurrent DVT or pulmonary embolism
• Active ulcers detected by gastroscopy
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Receipt of extensive radiation therapy within 4 weeks

Sponsors & Collaborators

• Chonnam National University Hospital: lead

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, 519-809, South Korea

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Thalidomide; Cyclophosphamide; Dexamethasone; Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines

Central Study Contacts

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

CONTACT

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

Deok-Hwan Yang, M.D. and Ph.D.

CONTACT

82-61-3797636; drydh1685@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: April 30, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Last Updated: September 22, 2011

Record last verified: 2011-09

Locations

KR (1)