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Bortezomib, Dexamethasone, and Cyclophosphamide in Treating Older Patients With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02082405
Recruitment Status : Withdrawn (Funding unavailable)
First Posted : March 10, 2014
Last Update Posted : April 24, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:
This phase II trial studies the side effects and how well lower doses of bortezomib, dexamethasone, and cyclophosphamide work in treating older patients with multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving cyclophosphamide daily may kill more cancer cells. Giving bortezomib, cyclophosphamide, and dexamethasone may be an effective treatment for multiple myeloma.

Condition or disease Intervention/treatment Phase
Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma Drug: bortezomib Drug: cyclophosphamide Drug: dexamethasone Other: laboratory biomarker analysis Other: quality-of-life assessment Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the overall response rate (ORR) and toxicity rate of therapy with weekly bortezomib combined with oral metronomic cyclophosphamide and low-dose dexamethasone.

SECONDARY OBJECTIVES:

I. To determine overall survival. II. To describe the association between disease status, treatment response, treatment toxicity, quality of life, functional status, risk for development of frailty, and inflammatory cytokine levels.

OUTLINE:

Patients receive bortezomib subcutaneously (SC) or intravenously (IV) over 3-5 seconds on days 1, 8, and 15; cyclophosphamide orally (PO) once daily (QD) on days 1-21; and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and then every 3 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Weekly Bortezomib and Dexamethasone With Oral Metronomic Cyclophosphamide in Elderly Patients With Plasma Cell Myeloma
Study Start Date : April 2015
Estimated Primary Completion Date : August 2016


Arm Intervention/treatment
Experimental: Treatment (bortezomib, cyclophosphamide, dexamethasone)
Patients receive bortezomib SC or IV over 3-5 seconds on days 1, 8, and 15; cyclophosphamide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Drug: bortezomib
Given SC or IV
Other Names:
  • LDP 341
  • MLN341
  • VELCADE

Drug: cyclophosphamide
Given PO
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana

Drug: dexamethasone
Given PO
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM

Other: laboratory biomarker analysis
Optional correlative studies

Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment




Primary Outcome Measures :
  1. Overall Response rate in accordance with the IMWG Uniform Response criteria [ Time Frame: Up to 7 months ]
    The number of people with any response as defined by the IMWG criteria

  2. Incidence of toxicities according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 7 months ]

Secondary Outcome Measures :
  1. Changes in quality of life as assessed by the Functional Assessment of Cancer Therapy-General [ Time Frame: Up to 24 weeks ]
    Changes in quality of life at baseline to the end of treatment estimated by means with confidence intervals. Quality of life will be assessed using the 34 item general functional assessment of cancer therapy (FACT-G) questionnaire.

  2. Changes in functional status [ Time Frame: Up to 24 weeks ]
    Changes in functional status at baseline to the end of treatment estimated by means with confidence intervals. Functional status will be assessed by scoring the thirteen item Vulnerable Elders Survey (VES-13).

  3. Overall Survival [ Time Frame: 24 Weeks ]
    The number of people alive after 24 weeks on the study

  4. Changes in quality of life as assessed by the Functional Assessment of Cancer Therapy-General [ Time Frame: After 6 weeks (2 courses) of treatment ]
    Average changes in quality of life at baseline estimated by means with confidence intervals.Quality of life will be assessed using the 34 item general functional assessment of cancer therapy (FACT-G) questionnaire.

  5. Changes in functional status [ Time Frame: After 6 weeks (2 courses) of treatment ]
    Changes in functional status at baseline to the second course 2 of therapy estimated by means with confidence intervals. Functional status will be assessed by scoring the thirteen item Vulnerable Elders Survey (VES-13).



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a confirmed diagnosis of symptomatic myeloma in accordance with International Myeloma Working group (IMWG) criteria

    • Bone marrow plasmacytosis with > 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma
    • Symptomatic disease, i.e., end-organ damage due to multiple myeloma (MM) including at least one of the following: anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fracture), or renal dysfunction
  • Absolute neutrophil count (ANC) >= 1000 cells/mm^3 (without use of growth factors)
  • Platelets >= 50,000 cells/mm^3
  • Direct bilirubin =< 1.5 X upper limit of normal (ULN); elevated bilirubin is permissible if patient has a known history of elevated bilirubin due to Gilbert's or if elevated bilirubin is due to hemolysis
  • Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 X ULN
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Prior treatment with > 1 cycle of any plasma cell myeloma (PCM) induction regimen (maximum 6 weeks of prior treatment)

    • Prior radiation therapy is allowed
    • Prior treatment for other cancers is allowed as long as patient meets criteria for adequate hematopoietic and organ function and is not actively on chemotherapy for another cancer
  • Grade >= 2 peripheral neuropathy
  • Second malignancy currently undergoing chemotherapy or radiotherapy; hormonal therapy for breast or prostate cancer is allowed
  • Patients may not be receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, cyclophosphamide, dexamethasone or other agents used in this study
  • Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

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): NCT02082405


Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Erica Campagnaro Case Comprehensive Cancer Center
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02082405    
Other Study ID Numbers: CASE3A13
NCI-2014-00250 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE 3A13 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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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
Cyclophosphamide
Bortezomib
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents