Trial Outcomes & Findings for A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life (NCT NCT00222105)

Results Overview

Response rate after completion of first cycle. Measured as the proportion of subjects who have a partial response (PR) or complete response (CR), represented as the overall response rate (ORR). SWOG/IBMTR (Southwest Oncology Group/International Blood and Marrow Transplant Research) criteria utilized to determine multiple myeloma response rates.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

At End of Cycle 1, 28 Days

Results posted on

2017-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 Doxil, Thalidomide, Dexamethasone Doxil: Doxil 40 mg/m2 IV day 1 Thalidomide: 50-100 mg day 1-28 Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18
Overall Study STARTED	25
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 Doxil, Thalidomide, Dexamethasone Doxil: Doxil 40 mg/m2 IV day 1 Thalidomide: 50-100 mg day 1-28 Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18
Overall Study Removed due to wrong diagnosis	1
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	8
Overall Study Treatment delays	2
Overall Study Death	2

Baseline Characteristics

A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=25 Participants Doxil, Thalidomide, Dexamethasone Doxil: Doxil 40 mg/m2 IV day 1 Thalidomide: 50-100 mg day 1-28 Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18
Age, Continuous	61 years n=99 Participants
Sex: Female, Male Female	8 Participants n=99 Participants
Sex: Female, Male Male	17 Participants n=99 Participants
Region of Enrollment United States	25 Participants n=99 Participants

PRIMARY outcome

Timeframe: At End of Cycle 1, 28 Days

Population: Five subjects did not complete first cycle.

Response rate after completion of first cycle. Measured as the proportion of subjects who have a partial response (PR) or complete response (CR), represented as the overall response rate (ORR). SWOG/IBMTR (Southwest Oncology Group/International Blood and Marrow Transplant Research) criteria utilized to determine multiple myeloma response rates.

Outcome measures

Outcome measures
Measure	Arm 1 n=20 Participants Doxil, Thalidomide, Dexamethasone Doxil: Doxil 40 mg/m2 IV day 1 Thalidomide: 50-100 mg day 1-28 Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18
Overall Response Rate	95 percentage of participants

SECONDARY outcome

Timeframe: End of study, up to 12 months

Count of Participants with adverse events.

Outcome measures

Outcome measures
Measure	Arm 1 n=25 Participants Doxil, Thalidomide, Dexamethasone Doxil: Doxil 40 mg/m2 IV day 1 Thalidomide: 50-100 mg day 1-28 Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18
Toxicity	10 Participants

Adverse Events

Arm 1

Serious events: 8 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 n=25 participants at risk Doxil, Thalidomide, Dexamethasone Doxil: Doxil 40 mg/m2 IV day 1 Thalidomide: 50-100 mg day 1-28 Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18
Infections and infestations Infection	20.0% 5/25 • Number of events 5
Renal and urinary disorders Acute Renal Failure	4.0% 1/25 • Number of events 1
Metabolism and nutrition disorders Dehydration	4.0% 1/25 • Number of events 1
Cardiac disorders Arrhythmia	4.0% 1/25 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Cancer Center Clinical Trials Office

University of Kansas Medical Center

Phone: (913) 945-5059

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place