Trial Outcomes & Findings for Zevalin for Patients With Incomplete Response to Chemo Prior to Autologous Stem Cell Transplant for Multiple Myeloma (NCT NCT01207765)

NCT ID: NCT01207765

Last Updated: 2017-03-20

Results Overview

Efficacy: objective response rate (CR + PR) at 12 and 104 days following radioimmunotherapy. Safety: the rate of occurrence of defined toxic events including non-engraftment and unacceptable biodistribution of 90Y Zevalin occurring by day +42 following transplant. Response determined according to Blade' Criteria (Bladé J, Br J Haematol.1998 Sep;102(5):1115-23) for multiple myeloma; Response based on reduction of monoclonal protein (M-protein) from initial presentation.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Through day +104 following immunotherapy

Results posted on

2017-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	Zevalin 1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Zevalin for Patients With Incomplete Response to Chemo Prior to Autologous Stem Cell Transplant for Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zevalin n=8 Participants 1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	7 Participants n=99 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	8 participants n=99 Participants

PRIMARY outcome

Timeframe: Through day +104 following immunotherapy

Population: 6 subjects had objectively measurable disease and were evaluable for response, 8 subjects received study intervention and are evaluable for safety

Outcome measures

Outcome measures
Measure	Zevalin n=8 Participants 90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
Safety and Efficacy CR/PR at +12 days	1 participants
Safety and Efficacy CR/PR at +104 days	5 participants
Safety and Efficacy Participants with toxic events	5 participants

SECONDARY outcome

Timeframe: Transplant through day 42

Population: Analyzed on intent-to-treat basis

Number of days from stem cell infusion (day +0) to day of neutrophil engraftment (first of three consecutive days with absolute neutrophil count \> 500)

Outcome measures

Outcome measures
Measure	Zevalin n=8 Participants 90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
Time to Engraftment in Patients Who Proceed to Myeloablative Chemotherapy After Receiving 90Y Zevalin® (Ibritumomab Tiuxetan).	13 Days Interval 9.0 to 31.0

SECONDARY outcome

Timeframe: 2 weeks prior - 2 weeks post transplant

Population: Immunohistochemical analysis showed inconsistent / insufficient CD20 staining on surface of plasma cells; comparisons could not be made

CD20 immunohistochemical staining of plasma cells on baseline bone marrow biopsy specimen, graded on qualitative scale (0 to +++)

Outcome measures

Outcome data not reported

Adverse Events

Zevalin

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zevalin n=8 participants at risk 1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
Blood and lymphatic system disorders Septic thrombophlebitis	12.5% 1/8 • Number of events 1
Infections and infestations Perianal absess	12.5% 1/8 • Number of events 1
Nervous system disorders Myoclonus	12.5% 1/8 • Number of events 1

Other adverse events

Other adverse events
Measure	Zevalin n=8 participants at risk 1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
Infections and infestations MRSA bacteremia	12.5% 1/8 • Number of events 1
Infections and infestations S. viridans bacteremia	12.5% 1/8 • Number of events 1
Infections and infestations S. epidermitis	12.5% 1/8 • Number of events 1

Additional Information

Andreas Klein, MD

Tufts Medical Center

Phone: 617-636-8884

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place