Trial Outcomes & Findings for Phase I/II Trial of the Combination of Lenalidomide (Revlimid) and Nab-paclitaxel (Abraxane) in the Treatment of Relapsed/Refractory Multiple Myeloma (NCT NCT02075021)

Results Overview

Dose limiting toxicity will be accessed based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

3 participants

Primary outcome timeframe

4 weeks

Results posted on

2018-10-15

Participant Flow

Confirmed diagnosis of relapsed/refractory multiple myeloma.

Participant milestones

Participant milestones
Measure	Lenalidomide and Nab-paclitaxel 100 mg/m\^2 of Abraxane weekly for 3 weeks and 10 mg Revlimid daily for 21 days, with a dose escalation for Revlimid to 15 mg and to 25 mg. One cycle is 4 weeks. Dose de-escalations will also be performed for both drugs as necessary. Patients will be treated until disease progression. Lenalidomide nab-paclitaxel
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase I/II Trial of the Combination of Lenalidomide (Revlimid) and Nab-paclitaxel (Abraxane) in the Treatment of Relapsed/Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenalidomide and Nab-paclitaxel n=3 Participants 100 mg/m\^2 of Abraxane weekly for 3 weeks and 10 mg Revlimid daily for 21 days, with a dose escalation for Revlimid to 15 mg and to 25 mg. One cycle is 4 weeks. Dose de-escalations will also be performed for both drugs as necessary. Patients will be treated until disease progression. Lenalidomide nab-paclitaxel
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Results were not analyzed due to lack of sufficient data. PI left the institution.

Dose limiting toxicity will be accessed based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 years

Population: Results were not analyzed due to lack of sufficient data. PI left the institution.

The response will be determined using the International Uniform Response Criteria for Multiple Myeloma.

Outcome measures

Outcome data not reported

Adverse Events

Lenalidomide and Nab-paclitaxel

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

Amitabha Mazumder, MD

NYU Clinical Cancer Center

Phone: (212) 731-5757

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place