Trial Outcomes & Findings for Tandem Transplantation in Multiple Myeloma (MM) Patients With <12 Months of Prior Treatment (NCT NCT00670631)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

After enrollment of 204 subjects is completed

Results posted on

2017-08-31

Participant Flow

Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.

Participant milestones

Participant milestones
Measure	Tandem Autologous Stem Cell Transplant Induction: DPACE chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required. After collection, participants will receive dexamethasone x 4 days every 14 days.
Overall Study STARTED	0
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tandem Transplantation in Multiple Myeloma (MM) Patients With <12 Months of Prior Treatment

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: After enrollment of 204 subjects is completed

Population: Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Interim analyses for safety will be performed after 20, 100, 200, and 300 patients have been enrolled.

Population: Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After 204 patients have been enrolled

Population: Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.

Outcome measures

Outcome data not reported

Adverse Events

Tandem Autologous Stem Cell Transplant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Guido Tricot, MD, PhD

University of Iowa

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place