Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04) (IFM2013-04)

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.
ClinicalTrials.gov Identifier: NCT01971658
Recruitment Status : Completed
First Posted : October 29, 2013
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

This is a phase III, multicenter, prospective with a clinical benefit, open-label and randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly Diagnosed Multiple Myeloma.

Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4 consecutive 21 day cycles of an induction treatment with either VTD or VCD.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Thalidomide® Drug: Cyclophosphamide Drug: Velcade® Drug: Dexaméthasone Phase 3

Detailed Description:

The patient population will consist of adult men and women who have a confirmed diagnosis of Multiple Myeloma and who meet eligibility criteria. They will be recruited from among the patients consulting in an investigating centre's haematology service for newly diagnosed, symptomatic, untreated multiple myeloma.

in each treatment arm there will be :

  1. Induction therapy : 4 cycles of VTD (21 days)or VCD
  2. Systematic stem cell harvest after cycle 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE III STUDY OF VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD) VERSUS VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD) AS AN INDUCTION TREATMENT PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA."
Study Start Date : October 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015


Arm Intervention/treatment
Active Comparator: VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD)

Arm A:

  1. Induction therapy 4 cycles of VTD (21 days) Thalidomide® 100 mg/day Per Os Day1 to Day21 Velcade® 1.3 mg/m²/day Subcutaneous Day1, 4, 8 and 11 Dexamethasone 40 mg/day Per Os Day 1 to 4 and Day 9 to 12
  2. Systematic stem cell harvest after cycle 3 Mobilization: Cyclophosphamide and one week after the last dose of Thalidomide, stem cells have to be harvested
Drug: Thalidomide®
Drug: Velcade®
Drug: Dexaméthasone
Active Comparator: VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD)

For arm B:

  1. Induction therapy : 4 cycles of VCD (21 days)

    • Cyclophosphamide 500 mg/m²/day, Per Os Day 1, 8, 15
    • Velcade® and Dexamethasone identical treatment to Arm A
  2. Systematic stem cell harvest after cycle 3 Mobilization: Cyclophosphamide and two weeks after the last dose of Cyclophosphamide, stem cells have to be harvested
Drug: Cyclophosphamide
Drug: Velcade®
Drug: Dexaméthasone



Primary Outcome Measures :
  1. Response assessment according to the criteria IMWG [ Time Frame: 15-17 month ]
    compare the Response assessment in both arms: the Very good partial remission rate (according to the criteria IMWG) achieved with four courses of VTD with that achieved with four courses of VCD


Secondary Outcome Measures :
  1. Response assessment according to the criteria IMWG [ Time Frame: 15 - 17 month ]
    compare the Response assessment in both arms: the following parameters after induction treatment with four courses of VTD or four courses of VCD the Complete remission rate (according to the criteria IMWG)

  2. Number of Adverse Events [ Time Frame: 15-17 month ]
    To evaluate the Safety of induction therapy

  3. Number of collected stem cell [ Time Frame: 17 month ]
  4. Number of death [ Time Frame: 17 month ]
    To evaluate Overall and Progression-Free Survival

  5. Response assessment according to the criteria IMWG [ Time Frame: 15-17 month ]
    compare the Response assessment in both arms: Compare the following parameters after induction treatment with four courses of VTD or four courses of VCD the Partial remission rate (according to the criteria IMWG)

  6. Number of relapse according to the criteria IMWG [ Time Frame: 17 month ]
    Progression-Free Survival


Other Outcome Measures:
  1. Comparison of three techniques for the quantification of urinary monoclonal components in patients with Newly Diagnosed Multiple Myeloma. [ Time Frame: 17 month ]

    The detection and the estimation of the urinary monoclonal components is an inescapable element of the diagnosis and the evaluation of the therapeutic efficacy in the myeloma.

    Urinary protein, electrophoresisin agarose gel is the quantitative method of choice. In these labs, the quantification of the urinary monoclonal peak is not performed. In the absence of quantitative data on urinary monoclonal components, the patient is considered as non-assessable. Recently, the company Sebia has developed the quantification on two other materials used specifically for the characterization of monoclonal component and / or proteinuria (HYDRAGEL BENCE JONES and HYDRAGEL URINE PROFILE).

    The objective of this study is to compare the quantification of monoclonal components between the reference HR electrophoresis technique and the other two above-mentioned techniques.




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.


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

Inclusion Criteria:

Patients newly diagnosed with symptomatic Multiple Myeloma (MM) patient

  1. - 18 ≤ age < 66 years
  2. - Eastern Cooperative Oncology Group Performance Status of 0, 1 or 2
  3. - Patients must be eligible for Autologous Stem Cell Transplantation
  4. - Patients must have measurable disease by serum M-protein ≥ 10 g/L and/or urine M-protein ≥200mg/day
  5. - Female patients of child-bearing potential (FCBP):

    • Must agree to have medically supervised pregnancy tests prior to starting study and every 21 days, including 4 weeks after the end of study treatment. This applies even if the patient practices complete and continued sexual abstinence.
    • Must agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy.
  6. - Male Patients:

    • Must agree to use a condom during sexual contact with a FCBP, throughout study drug therapy, during any dose interruption and for one week after discontinuation of study therapy
    • Must agree to not donate semen during study drug therapy and for one week after discontinuation of study therapy
  7. - All patients must:

    • Agree to abstain from donating blood while taking study drug therapy and for one week after discontinuation of study drug therapy
    • Agree not to share study medication with another person.
  8. - Patients must be capable of giving informed consent
  9. - Patients must be affiliated with French social security system

Exclusion Criteria:

  1. - Asymptomatic Multiple myeloma
  2. - Non-secretory Multiple myeloma
  3. - Proven AL-amyloidosis
  4. - Age ≥ 66 years old
  5. - Prior or current systemic therapy for Multiple myeloma, including steroids (except for emergency use of a 4-day block of dexamethasone before randomization, maximum total dose allowed 160 mg)
  6. - Radiation therapy in the 2 weeks preceding randomization
  7. - National Cancer Institute grade ≥ 2 peripheral neuropathy
  8. - Haemoglobin < 8g/dL
  9. - Absolute neutrophil count < 1,000 cells / µL, platelet count < 50,000 cells / µL
  10. - Creatinine level > 170 µmol/L or requiring dialysis.
  11. - Bilirubin, transaminases or GamaGT > 3 UNL (upper normal limit)
  12. - Positive HIV serology, evidence of active Hepatitis B and C infection
  13. - Severe active infection
  14. - Inability to comply with an anti-thrombotic treatment regimen
  15. - A personal medical history of severe psychiatric disease
  16. - Uncontrolled diabetes contraindicating the use of high-dose dexamethasone
  17. - Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment)
  18. - A personal medical history of cancer unless the patient has been without relapse after treatment discontinuation > or = 5 years (except for basocellular skin cancer or in situ cervical cancer)
  19. - Use of any investigational drug in the 30 days preceding randomization

22 - Pregnant or lactating women. 23 - Adults under juridical protection 24 - Known or suspected hypersensitivity to any of the study therapies or excipients 25 - Necessity of vaccination for yellow fever or with any other live vaccines


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 ClinicalTrials.gov identifier (NCT number): NCT01971658


  Show 63 Study Locations
Sponsors and Collaborators
Nantes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Philippe MOREAU Nantes University Hospital

Layout table for additonal information
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01971658     History of Changes
Other Study ID Numbers: RC13_0284
2013-003174-27 ( EudraCT Number )
First Posted: October 29, 2013    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015

Keywords provided by Nantes University Hospital:
Multiple myeloma
Newly Diagnosed

Additional relevant MeSH terms:
Layout table for 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
Dexamethasone
Dexamethasone acetate
Cyclophosphamide
Bortezomib
Thalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal