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ACVDL Treatment for Patients With Newly Diagnosed Multiple Myeloma (ACVDL)

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: NCT01481194
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Vejle Hospital

Tracking Information
First Submitted Date  ICMJE November 21, 2011
First Posted Date  ICMJE November 29, 2011
Last Update Posted Date March 1, 2019
Actual Study Start Date  ICMJE November 2011
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2011)
Response rate [ Time Frame: 4 weeks after completion of 8 treatment cycles ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01481194 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2011)
  • Complete response rate [ Time Frame: 4 weeks after completion of 8 treatment cycles ]
  • Very good partial response rate [ Time Frame: 4 weeks after completion of 8 treatment cycles ]
  • Time to progression [ Time Frame: 4 years ]
  • Progression free survival [ Time Frame: 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ACVDL Treatment for Patients With Newly Diagnosed Multiple Myeloma
Official Title  ICMJE An Open-Label Phase II Study of the Safety and Efficacy of Doxorubicin and Cyclophosphamide in Combination With Bortezomib, Lenalidomide, and Dexamethasone for Treatment of Patients With Newly Diagnosed Multiple Myeloma
Brief Summary The purpose of this study is to evaluate the efficacy and safety of the combination treatment of doxorubicin, cyclophosphamide, bortezomib, dexamethasone, and lenalidomide in newly diagnosed multiple myeloma patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: Doxorubicin
    50 mg/m2 IV on day 1 of a 21-day cycle
  • Drug: Bortezomib
    1.3 mg/m2 IV push on days 2 and 9 of a 21-day cycle
  • Drug: Lenalidomide
    15 mg orally on days 1-14 of a 21-day cycle
  • Drug: Dexamethasone
    20 mg orally on days 2, 3, 9, and 10 of a 21-day cycle
  • Drug: Cyclophosphamide
    750 mg/m2 IV on day 1 of a 21-day cycle
Study Arms  ICMJE Experimental: ACVDL
ACVDL is a combination of doxorubicin, cyclophosphamide, bortezomib, dexamethasone, and lenalidomide
Interventions:
  • Drug: Doxorubicin
  • Drug: Bortezomib
  • Drug: Lenalidomide
  • Drug: Dexamethasone
  • Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2013)
35
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2011)
30
Actual Study Completion Date  ICMJE August 28, 2018
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female subjects ≥ 18 years at the time of signing informed consent.
  2. Subject is diagnosed with symptomatic multiple myeloma based on the International Myeloma Working Group Diagnostic Criteria (Kyle 2009):

    • Monoclonal plasma cells in the bone marrow ≥ 10% and/or presence of a biopsy-proven plasmacytoma.
    • Monoclonal protein present in the serum and/or urine. If no monoclonal protein is detected (non-secretory disease), then ≥ 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma is required.
    • Myeloma-related organ dysfunction
  3. The myeloma disease burden must be measurable with at least one of the following criteria (Durie et al. 2006):

    • Serum M-protein ≥ 10 g/l
    • Urine M-protein ≥ 200 mg/24 h
    • Involved FLC ≥ 100 mg/l provided serum FLC ratio is abnormal
    • Bone marrow plasma cells > 30%
  4. Subject has a Karnofsky performance status of ≥ 60.
  5. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  6. Subject is willing and able to comply with the protocol as judged by the investigator.

Exclusion Criteria:

  1. Any prior systemic therapy for multiple myeloma.
  2. Other therapies such as biologic therapy and chemotherapy less than 3 months prior to screening.
  3. Any prior treatment with doxorubicin or other anthracycline.
  4. Concurrent or recent (less than 2 weeks prior to Screening) radiotherapy or surgery.
  5. Prior glucocorticoid treatment of multiple myeloma exceeding dexamethasone 20mg/day for a maximum of 7 days. Topical glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted.
  6. More than or equal to grade 2 peripheral neuropathy according to the NCI-CTC criteria on clinical examination within 14 days before enrolment (Day 1 of Cycle 1).
  7. Evidence of mucosal or internal bleeding and/or platelet counts < 50 x 10^9/l. Platelet transfusions may not be used to meet PLT eligibility criteria.
  8. Absolute neutrophil count (ANC) < 1 x 10^9/l. Growth factors may not be used to meet ANC eligibility criteria.
  9. Hemoglobin < 5.0 mmol/l. The subject may be included after correction of the hemoglobin level by transfusion or treatment with erythropoietin.
  10. Alanine aminotransferase (ALAT) > 2 x ULN.
  11. Myocardial infarction within 6 months prior to enrolment or New York Heart Association (NYHA) Class IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.
  12. Clinically relevant active infection or serious co-morbid medical conditions, such as chronic obstructive or chronic restrictive pulmonary disease, and cirrhosis.
  13. Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study.
  14. Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer for which the subject has been disease-free for at least 3 years.
  15. Female subject is pregnant or breast-feeding. The first serum pregnancy test to be done within 10-14 days prior to the study treatment start and repeated serum pregnancy test to be done within 24 hours prior to the start of study treatment.
  16. Female subjects who are of childbearing potential (biologically capable of becoming pregnant) or men with partners of childbearing potential, who are unwilling or unable to use effective means of contraception. The means of contraception must be TWO acceptable methods of birth control, one highly effective method (hormonal contraceptives pills, injections or implants, tubal ligation, partner's vasectomy) and one additional effective method (condom, diaphragm, cervical cap) AT THE SAME TIME, at least 28 days before she or he starts ACVDL and for at least 28 days after the last dose of ACVDL.
  17. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  18. Uncontrolled diabetes mellitus at the discretion of the investigator.
  19. Hypersensitivity and/or contraindication to any one of the Investigational Medicinal Products (IMP), acyclovir or similar anti-viral drug.
  20. POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes).
  21. Known HIV infection.
  22. Known active hepatitis B or C viral infection.
  23. Known intolerance to steroid therapy.
  24. Current or recent (within 30 days prior to Screening) treatment with another investigational drug.
  25. Unable to comply with the administration of the study treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01481194
Other Study ID Numbers  ICMJE SDU/VS-HKU/CTC-2011-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vejle Hospital
Study Sponsor  ICMJE Vejle Hospital
Collaborators  ICMJE The University of Hong Kong
Investigators  ICMJE
Study Chair: Torben Plesner, DMSc Vejle Hospital
PRS Account Vejle Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP