Trial Outcomes & Findings for A Phase I/II Study Evaluating Temferon in Multiple Myeloma Patients With Early Relapse After Front Line Therapy (TEM-MM) (NCT NCT03875495)

Results Overview

0 participants analyzed. All the patients were withdrawn before treatment

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

9 participants

Primary outcome timeframe

90 days

Results posted on

2022-01-28

Participant Flow

3 patients recruited but none received Temferon. Unable to recruit additional patients due to the ongoing COVID-19 pandemic.

Participant milestones

Participant milestones
Measure	Temferon Autologous CD34+-enriched hematopoietic progenitor cells exposed ex vivo to a specific lentiviral vector encoding for the human IFN-ɑ2 gene. Its expression is tightly controlled by the human TIE2 enhancer/promoter sequence and by a post-transcriptional regulation layer represented by target miRNA sequences. This enables suppression of IFN-ɑ2 expression in HSPCs, thereby further increasing the specificity of the delivery strategy for their Tie2 expressing myeloid cell progeny. Temferon: Genetically modified autologous HSPCs
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase I/II Study Evaluating Temferon in Multiple Myeloma Patients With Early Relapse After Front Line Therapy (TEM-MM)

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 90 days

Population: Untreated patients

0 participants analyzed. All the patients were withdrawn before treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

0 participants analyzed. All the patients were withdrawn before treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At least 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

Adverse Events

Untreated Patients

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

Chief Medical Officer

Genenta Science

Phone: +39 02 2643 3982

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place