ACVDL Treatment for Patients With Newly Diagnosed Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Vejle Hospital
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01481194
First received: November 21, 2011
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Doxorubicin
Drug: Bortezomib
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Cyclophosphamide
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: 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

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Response rate [ Time Frame: 4 weeks after completion of 8 treatment cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response rate [ Time Frame: 4 weeks after completion of 8 treatment cycles ] [ Designated as safety issue: No ]
  • Very good partial response rate [ Time Frame: 4 weeks after completion of 8 treatment cycles ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: November 2011
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACVDL
ACVDL is a combination of doxorubicin, cyclophosphamide, bortezomib, dexamethasone, and lenalidomide
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481194

Contacts
Contact: Torben Plesner, DMSc +45 7940 6313 torben.plesner@rsyd.dk
Contact: Maja Hinge, MD +45 7940 6342 maja.hinge@rsyd.dk

Locations
Denmark
Department of Hematology Recruiting
Vejle, Denmark
Contact: Torben Plesner, DMSc    +45 7940 6313    torben.plesner@rsyd.dk   
Contact: Maja Hinge, MD       maja.hinge@rsyd.dk   
Sub-Investigator: Maja Hinge, MD         
Sub-Investigator: Thomas Lund, MD         
Sponsors and Collaborators
Vejle Hospital
The University of Hong Kong
Investigators
Study Chair: Torben Plesner, DMSc Vejle Hospital
  More Information

No publications provided

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT01481194     History of Changes
Other Study ID Numbers: SDU/VS-HKU/CTC-2011-01
Study First Received: November 21, 2011
Last Updated: March 28, 2014
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Vejle Hospital:
Multiple Myeloma

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
Liposomal doxorubicin
Lenalidomide
Bortezomib
Dexamethasone
Doxorubicin
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on October 01, 2014