Bortezomib, Lenalidomide, and Dexamethasone in Treating Patients With Multiple Myeloma Undergoing Stem Cell Transplant

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02353468
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arm: 1
• Duration (Months): 22
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This phase II trial studies how well giving bortezomib, lenalidomide, and dexamethasone together works in treating patients with multiple myeloma undergoing stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib, lenalidomide, and dexamethasone together may kill more cancer cells.

Condition or Disease	Intervention/Treatment	Phase
Refractory Plasma Cell Myeloma	Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone	Phase 2

Detailed Description

CONSOLIDATION: Patients receive bortezomib, lenalidomide, and dexamethasone (VLD) therapy comprising bortezomib intravenously (IV) on days 1, 4, 8, and 11, lenalidomide orally (PO) once daily (QD) on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.

In between courses of VLD, patients receive Lenalidomide + Dexamethasone (LD) therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.

MAINTENANCE: Starting in the third year of therapy, patients receive lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study: Therapy With Bortezomib + Lenalidomide + Dexamethasone With Lenalidomide + Dexamethasone as Post Transplant Consolidation and Maintenance for Patients With Symptomatic Multiple Myeloma Following Autologous Transplantation
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Enzyme inhibitor, biological therapy, chemotherapy CONSOLIDATION: Patients receive VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity. In between courses of VLD, patients receive LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days. MAINTENANCE: Starting in the third year of therapy, patients receive lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Bortezomib; Given IV; Other Names: Velcade ; Drug: Lenalidomide; Given PO; Other Names: CC-5013 CC5013 CDC 501 IMiD-1 ; Drug: Dexamethasone; Given PO or IV; Other Names: Decadron

Outcome Measures

Primary Outcome Measures

1. Event Free Survival Rates by Land-mark Analysis [up to 5 years]

   A Kaplan-Meier curve would have been used to describe the distribution.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with symptomatic active multiple myeloma who have completed autotransplant are eligible for the study; patients should be assessed for eligibility within 35 days of the transplant and treatment should commence within 10 weeks of the transplant

• Performance status of 0-2 based on Southwest Oncology Group (SWOG) criteria; patients with a poor performance status (3-4) are also eligible, if complications of the bone such as compression fracture, hyperviscosity or infection such as pneumonia have been adequately treated

• No significant co-morbid medical conditions; no uncontrolled life threatening infection

• Unsupported platelet count > 80,000/uL

• Absolute neutrophil count (ANC) > 1000/uL

• Signed informed consent should be obtained from all patients in accordance with institutional and federal guidelines

Exclusion Criteria:

• Patients with a history of recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, difficult to control significant cardiac arrhythmias, or arrhythmia associated with prolonged QT interval

• Pregnant or nursing women; women of child-bearing potential must have a negative pregnancy documented within one week of registration; women/men of reproductive potential may not participate unless they have agreed to use two forms of effective contraceptive method

• Patients with a grade 3-4 neuropathy related to prior exposure to bortezomib, thalidomide, or other agents

• Human immunodeficiency virus (HIV) positive patients

• Transaminases > 2 x normal values

• Bilirubin > 2 x normal values

• Active uncontrolled infection

• History of significant psychiatric illness; steroid induced psychosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

• Principal Investigator: Choon-kee Lee, MD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT02353468
• Other Study ID Numbers: 08-0816.cc; NCI-2011-03113
• First Posted: Feb 2, 2015
• Last Update Posted: Mar 9, 2015
• Last Verified: Jan 1, 2015

• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Dexamethasone; Lenalidomide; Bortezomib

Study Results

Participant Flow

Recruitment Details	Between December 2009 and October 2011, 3 patients were enrolled in the study from University of Colorado Cancer Center
Pre-assignment Detail	35 days following autologous transplant, patients were evaluated for eligibility by the standard tests, including paraprotein assessment, bone marrow biopsy and aspiration, MRI scan, and PET/CT scan that is indicated for patients with hypo- or non-secretary myeloma.

Arm/Group Title	Enzyme Inhibitor, Biological Therapy, Chemotherapy
Arm/Group Description	CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity. In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days. MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Lenalidomide: Given PO Dexamethasone: Given PO or IV
Period Title: Overall Study
STARTED	3
COMPLETED	0
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Enzyme Inhibitor, Biological Therapy, Chemotherapy
Arm/Group Description	CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity. In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days. MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Lenalidomide: Given PO Dexamethasone: Given PO or IV
Overall Participants	3
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 100%
>=65 years	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	54.3 (3.8)
Sex: Female, Male (Count of Participants)
Female	2 66.7%
Male	1 33.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 100%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	3 100%

Outcome Measures

1. Primary Outcome

Title	Event Free Survival Rates by Land-mark Analysis
Description	A Kaplan-Meier curve would have been used to describe the distribution.
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

The study was terminated, study endpoints were not reached.

Arm/Group Title	Enzyme Inhibitor, Biological Therapy, Chemotherapy
Arm/Group Description	CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity. In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days. MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Lenalidomide: Given PO Dexamethasone: Given PO or IV
Measure Participants	0

Adverse Events

Time Frame	Patients were assessed for adverse events for approximately 2 years until the study was terminated.
Arm/Group Title	Enzyme Inhibitor, Biological Therapy, Chemotherapy
Arm/Group Description	CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity. In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days. MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Lenalidomide: Given PO Dexamethasone: Given PO or IV
All Cause Mortality
	Enzyme Inhibitor, Biological Therapy, Chemotherapy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Enzyme Inhibitor, Biological Therapy, Chemotherapy
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Other (Not Including Serious) Adverse Events
	Enzyme Inhibitor, Biological Therapy, Chemotherapy
	Affected / at Risk (%)	# Events
Total	0/3 (0%)

Limitations/Caveats

This study was terminated due to the investigator's departure from the institution.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.