Trial Outcomes & Findings for High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma (NCT NCT00349778)

NCT ID: NCT00349778

Last Updated: 2017-12-12

Results Overview

Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 102 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2017-12-12

Participant Flow

Participant milestones

Measure	High-Dose Sequential Therapy Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
Overall Study STARTED	102
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma

Baseline characteristics by cohort

Measure	High-Dose Sequential Therapy n=102 Participants Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	91 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Ethnicity · Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Ethnicity · Not Hispanic or Latino	85 Participants n=5 Participants
Ethnicity (NIH/OMB) Ethnicity · Unknown or Not Reported	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis.

Outcome measures

Measure	High-Dose Sequential Therapy n=102 Participants Cyclophosphamide + etoposide + melphalan + carmustine with filgrastim
Number of Participants With Pulmonary Toxicity	32 Participants

SECONDARY outcome

Timeframe: 5 years

Survival status was assessed 5 years after transplant.

Outcome measures

Measure	High-Dose Sequential Therapy n=102 Participants Cyclophosphamide + etoposide + melphalan + carmustine with filgrastim
Overall Participant Survival (OS)	52 Participants

SECONDARY outcome

Timeframe: 5 years

Relapse was measured as the number of patients who relapse after high-dose sequential therapy then autologous transplantation

Outcome measures

Measure	High-Dose Sequential Therapy n=102 Participants Cyclophosphamide + etoposide + melphalan + carmustine with filgrastim
Number of Participants That Relapse After Autologous Transplantation	66 Participants

Adverse Events

High-Dose Sequential Therapy

Serious events: 5 serious events

Other events: 0 other events

Deaths: 22 deaths

Serious adverse events

Measure	High-Dose Sequential Therapy n=102 participants at risk Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
Cardiac disorders Cardiogenic shock	0.98% 1/102 • Number of events 1 • 2 years
Infections and infestations Fungal infection	0.98% 1/102 • Number of events 1 • 2 years
Infections and infestations aspergillus infection	0.98% 1/102 • Number of events 1 • 2 years
Infections and infestations Interstitial pneumonitis	0.98% 1/102 • Number of events 1 • 2 years
Infections and infestations Infection	0.98% 1/102 • Number of events 1 • 2 years

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sally Arai

Stanford University

Phone: 650-723-0822

Email: sarai1@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place