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

NCT02082405 | Withdrawn Phase 2 DMC

• 4 other identifiers: CASE3A13NCI-2014-00250CASE 3A13P30CA043703
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Overall Response rate in accordance with the IMWG Uniform Response criteria

  The number of people with any response as defined by the IMWG criteria

  Up to 7 months

• Incidence of toxicities according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4

  Up to 7 months

Secondary Outcomes (5)

• Changes in quality of life as assessed by the Functional Assessment of Cancer Therapy-General

  Up to 24 weeks

• Changes in functional status

  Up to 24 weeks

• Overall Survival

  24 Weeks

• Changes in quality of life as assessed by the Functional Assessment of Cancer Therapy-General

  After 6 weeks (2 courses) of treatment

• Changes in functional status

  After 6 weeks (2 courses) of treatment

Study Arms (1)

Treatment (bortezomib, cyclophosphamide, dexamethasone)

EXPERIMENTAL

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; Drug: cyclophosphamide; Drug: dexamethasone; Other: laboratory biomarker analysis; Other: quality-of-life assessment

Interventions

bortezomib DRUG

Given SC or IV

Also known as: LDP 341, MLN341, VELCADE

Treatment (bortezomib, cyclophosphamide, dexamethasone)

cyclophosphamide DRUG

Given PO

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana

Treatment (bortezomib, cyclophosphamide, dexamethasone)

dexamethasone DRUG

Given PO

Also known as: Aeroseb-Dex, Decaderm, Decadron, DM, DXM

Treatment (bortezomib, cyclophosphamide, dexamethasone)

laboratory biomarker analysis OTHER

Optional correlative studies

Treatment (bortezomib, cyclophosphamide, dexamethasone)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Treatment (bortezomib, cyclophosphamide, dexamethasone)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Cyclophosphamide; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Erica Campagnaro

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: April 1, 2015
• Primary Completion: August 1, 2016
• Last Updated: April 24, 2015

Record last verified: 2015-04