Trial Outcomes & Findings for Bortezomib, Lenalidomide, and Dexamethasone in Treating Patients With Multiple Myeloma Undergoing Stem Cell Transplant (NCT NCT02353468)

NCT ID: NCT02353468

Last Updated: 2015-03-09

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: up to 5 years
• Results posted on: 2015-03-09

Participant Flow

Between December 2009 and October 2011, 3 patients were enrolled in the study from University of Colorado Cancer Center

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.

Participant milestones

Measure	Enzyme Inhibitor, Biological Therapy, Chemotherapy 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 Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure

Enzyme Inhibitor, Biological Therapy, Chemotherapy 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 Study Study terminated

3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Enzyme Inhibitor, Biological Therapy, Chemotherapy n=3 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	54.3 Years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 5 years

Population: The study was terminated, study endpoints were not reached.

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

Outcome measures

Outcome data not reported

Adverse Events

Enzyme Inhibitor, Biological Therapy, Chemotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Choon-kee Lee, MD

University of Colorado

Phone: 7208489252

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place