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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01114048
Recruitment Status : Unknown
Verified September 2011 by Chonnam National University Hospital.
Recruitment status was:  Recruiting
First Posted : April 30, 2010
Last Update Posted : September 22, 2011
Information provided by:
Chonnam National University Hospital

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Thalidomide, cyclophosphamide, dexamethasone, bortezomib Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2010
Estimated Primary Completion Date : March 2012

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

Primary Outcome Measures :
  1. response rate for induction chemotherapy [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01114048

Contact: Je-Jung Lee, M.D. and Ph.D. 82-61-3797638
Contact: Deok-Hwan Yang, M.D. and Ph.D. 82-61-3797636

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

Responsible Party: Je-Jung Lee, associate professor, Chonnam National University Hwasun Hospital Identifier: NCT01114048     History of Changes
Other Study ID Numbers: KMM-97
First Posted: April 30, 2010    Key Record Dates
Last Update Posted: September 22, 2011
Last Verified: September 2011

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
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal