Trial Outcomes & Findings for DT PACE, Tandem Autologous Transplant, Maintenance Therapy for Waldenstrom's Macroglobulinemia Patients (NCT NCT00107614)

Results Overview

To evaluate the complete and partial response rates, defined in a strict manner, to a brief remission induction treatment with one or two courses of melphalan-based high-dose treatment (HDT) in symptomatic patients with Waldenström's Macroglobulinemia (WM), either untreated or previously treated.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

3 years

Results posted on

2011-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Waldenstrom's Macroglobulinemia Patients Participants must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
Overall Study STARTED	12
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Waldenstrom's Macroglobulinemia Patients Participants must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
Overall Study Physician Decision	10
Overall Study Death	2

Baseline Characteristics

DT PACE, Tandem Autologous Transplant, Maintenance Therapy for Waldenstrom's Macroglobulinemia Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Waldenstrom's Macroglobulinemia Patients n=12 Participants Participants must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=99 Participants
Age, Categorical >=65 years	6 Participants n=99 Participants
Age Continuous	65 years STANDARD_DEVIATION 11.0 • n=99 Participants
Sex: Female, Male Female	4 Participants n=99 Participants
Sex: Female, Male Male	8 Participants n=99 Participants

PRIMARY outcome

Timeframe: 3 years

To evaluate the complete and partial response rates, defined in a strict manner, to a brief remission induction treatment with one or two courses of melphalan-based high-dose treatment (HDT) in symptomatic patients with Waldenström's Macroglobulinemia (WM), either untreated or previously treated.

Outcome measures

Outcome data not reported

Adverse Events

Waldenstrom's Macroglobulinemia Patients

Serious events: 6 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Waldenstrom's Macroglobulinemia Patients n=12 participants at risk Participants must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
General disorders splenic infarction	8.3% 1/12 • Number of events 1
Infections and infestations septicemia	8.3% 1/12 • Number of events 1
General disorders peritonitis	16.7% 2/12 • Number of events 2
General disorders pneumonia	16.7% 2/12 • Number of events 2

Other adverse events

Other adverse events
Measure	Waldenstrom's Macroglobulinemia Patients n=12 participants at risk Participants must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
Blood and lymphatic system disorders febrile neutropenia	8.3% 1/12 • Number of events 1
General disorders dehydration	8.3% 1/12 • Number of events 1
Gastrointestinal disorders nausea, vomiting, diarrhea & fever	8.3% 1/12 • Number of events 1
General disorders mucositis	16.7% 2/12 • Number of events 2
Gastrointestinal disorders colitis	8.3% 1/12 • Number of events 1
Cardiac disorders hypotension	8.3% 1/12 • Number of events 1
Musculoskeletal and connective tissue disorders septic arthritis	8.3% 1/12 • Number of events 1

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