Trial Outcomes & Findings for 2006-32 Phase II Study of Rapidly Recycled High Dose DTPACE (NCT NCT00577512)

Results Overview

Complete Response (CR) defined as all of the following for a minimum of 2 months: a) absence of urine and serum M-components by immunofixation; b) bone marrow should be adequately cellular (\>20%); c) normal serum calcium; d) no new bone lesions or enlargement of existing lesions. Near Complete Response included all elements of CR except immunofixation studies remained positive.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

12 months

Results posted on

2017-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	HD DTPACE 1. High dose DTPACE (dexamethasone 200 mg days 1-7; thalidomide 200 mg days 1-4; cisplatin 15 mg/m2 days 1-4; adriamycin 15 mg/m2 days 1-4; cyclophosphamide 600 mg/m2 days 1-4; etoposide 60 mg/m2 days 1-4) and stem cell collection if you do not already have sufficient stem cells stored 2. High dose DTPACE and stem cell re-infusion repeated every 18-21 days for 4 cycles 3. Bortezomib (1.0 mg/m2 Day 1, 4, 8, 11), thalidomide (100 mg/m2 days 1-21), and dexamethasone (20 mg days 1-4 and 9-12) (VTD) Maintenance therapy
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

2006-32 Phase II Study of Rapidly Recycled High Dose DTPACE

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HD DTPACE n=4 Participants 1. High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored 2. High dose DTPACE and stem cell re-infusion 3. VTD Maintenance therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	54.3 years STANDARD_DEVIATION 6.24 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Complete Response (CR) defined as all of the following for a minimum of 2 months: a) absence of urine and serum M-components by immunofixation; b) bone marrow should be adequately cellular (\>20%); c) normal serum calcium; d) no new bone lesions or enlargement of existing lesions. Near Complete Response included all elements of CR except immunofixation studies remained positive.

Outcome measures

Outcome measures
Measure	HD DTPACE n=4 Participants 1. High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored 2. High dose DTPACE and stem cell re-infusion 3. VTD Maintenance therapy
Number of Subjects Treated With (HD DTPACE Obtain a Complete Response or Near Complete Response That Lasts for 6 Months or Longer.	0 participant response

Adverse Events

HD DTPACE

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HD DTPACE n=4 participants at risk 1. High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored 2. High dose DTPACE and stem cell re-infusion 3. VTD Maintenance therapy
General disorders hypoxemia	25.0% 1/4 • Number of events 1
Blood and lymphatic system disorders DVT	25.0% 1/4 • Number of events 4
General disorders cellulitis	25.0% 1/4 • Number of events 1
General disorders pneumonia	25.0% 1/4 • Number of events 1
General disorders shortness of breath, cough, extreme weakness	25.0% 1/4 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Nathan M. Petty

University of Arkansas for Medical Sciences, Myeloma Institute

Phone: 501-526-6990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place