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Early Response-adapted Intensification of Induction Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma (MM) (KMM-97)

This study is currently recruiting participants.
Verified September 2011 by Chonnam National University Hospital
Sponsor:
Information provided by:
Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT01114048
First received: April 28, 2010
Last updated: September 21, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
 Drug: Thalidomide, cyclophosphamide, dexamethasone, bortezomib
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Further study details as provided by Chonnam National University Hospital:

Primary Outcome Measures:
  • response rate for induction chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 78
Study Start Date: March 2010
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Thalidomide, cyclophosphamide, dexamethasone, bortezomib
    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
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114048

Contacts
Contact: Je-Jung Lee, M.D. and Ph.D. 82-61-3797638 drjejung@chonnam.ac.kr
Contact: Deok-Hwan Yang, M.D. and Ph.D. 82-61-3797636 drydh1685@gmail.com

Locations
Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-809
Principal Investigator: Je-Jung Lee, M.D. and Ph.D.            
Sponsors and Collaborators
Chonnam National University Hospital
  More Information

No publications provided

Responsible Party: Je-Jung Lee, associate professor, Chonnam National University Hwasun Hospital
ClinicalTrials.gov Identifier: NCT01114048     History of Changes
Other Study ID Numbers: KMM-97
Study First Received: April 28, 2010
Last Updated: September 21, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Chonnam National University Hospital:
age under 65
Previous untreated

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
 Thalidomide
Bortezomib
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013