Trial Outcomes & Findings for Study of Multiple Myeloma Patients Relapsing or Progressing After Autologous Transplantation on Total Therapy 2 (NCT NCT00573391)

Results Overview

due to low accrual rates, no analyses was done to compare the new combination of Velcade/Melphalan/Dexamethasone vs. Velcade/Thalidomide/Dexamethasone

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

5 participants

Primary outcome timeframe

24 months

Results posted on

2011-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	Velcade, Thalidomide, and Dexamethasone Velcade 1.0 mg/m\^2 Velcade 1.3 mg/m\^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m\^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11	VMD With Melphalan Dose Escalation VMD: Velcade 1.3 mg/m\^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m\^2) Melphalan 4 (6, 8, 10) mg/m\^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10
Overall Study STARTED	3	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Velcade, Thalidomide, and Dexamethasone Velcade 1.0 mg/m\^2 Velcade 1.3 mg/m\^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m\^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11	VMD With Melphalan Dose Escalation VMD: Velcade 1.3 mg/m\^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m\^2) Melphalan 4 (6, 8, 10) mg/m\^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10
Overall Study study stopped	2	2
Overall Study Death	1	0

Baseline Characteristics

Study of Multiple Myeloma Patients Relapsing or Progressing After Autologous Transplantation on Total Therapy 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Velcade, Thalidomide, and Dexamethasone n=3 Participants Velcade 1.0 mg/m\^2 Velcade 1.3 mg/m\^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m\^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11	VMD With Melphalan Dose Escalation n=2 Participants VMD: Velcade 1.3 mg/m\^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m\^2) Melphalan 4 (6, 8, 10) mg/m\^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

due to low accrual rates, no analyses was done to compare the new combination of Velcade/Melphalan/Dexamethasone vs. Velcade/Thalidomide/Dexamethasone

Outcome measures

Outcome data not reported

Adverse Events

Velcade, Thalidomide, and Dexamethasone

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

VMD With Melphalan Dose Escalation

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Velcade, Thalidomide, and Dexamethasone n=5 participants at risk Velcade 1.0 mg/m\^2 Velcade 1.3 mg/m\^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m\^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11	VMD With Melphalan Dose Escalation n=5 participants at risk VMD: Velcade 1.3 mg/m\^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m\^2) Melphalan 4 (6, 8, 10) mg/m\^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10
General disorders fever	20.0% 1/5 • Number of events 1	20.0% 1/5 • Number of events 1

Other adverse events

Other adverse events
Measure	Velcade, Thalidomide, and Dexamethasone n=5 participants at risk Velcade 1.0 mg/m\^2 Velcade 1.3 mg/m\^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m\^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11	VMD With Melphalan Dose Escalation n=5 participants at risk VMD: Velcade 1.3 mg/m\^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m\^2) Melphalan 4 (6, 8, 10) mg/m\^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10
Cardiac disorders secondary pulmonary hypertension	20.0% 1/5 • Number of events 1	0.00% 0/5
General disorders pneumonia	20.0% 1/5 • Number of events 1	0.00% 0/5

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