Clinical trial NCT02075021
Conditions: Relapsed or Refractory Multiple Myeloma
Keywords: relapsed refractory multiple myeloma revlimid lenalidomide abraxane n-paclitaxel
Sponsor: NYU Langone Health
Start date: 2014-03-01; Completion date: 2015-11-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators will perform a phase I/II trial of Revlimid daily for 21 days and Abraxane weekly for 3 weeks. Accrual will be on standard cohorts of 3 patients. Once the maximum toxicity dose (MTD) is reached, the level below will be expanded to 25 patients for a pilot phase II trial. All treatments will be performed until progression. Assessments will be made at least at the 2, 4 and 6 month timepoints and monthly thereafter until progression.

The purpose of this research study is to determine how much of the combination of Revlimid and Abraxane can be given safely and how well they work together against the cancer.

Currently, this trial is in the phase 1 stage.

Detailed description:
Revlimid is an important imid based therapy of myeloma. However patients will still relapse after this drug and then have limited options. Abraxane has shown efficacy in a number of cancers, putatively through intratumor concentration by SPARC (secreted protein acidic and rich in cysteine). (Taxanes have shown a modest activity in myeloma. Interestingly, Revlimid can upregulate the levels of SPARC. Thus, investigators will test the toxicity and efficacy of a combination of Revlimid and Abraxane in relapsed/refractory myeloma.

Investigators will perform a phase I/II trial of Revlimid daily for 21 days and Abraxane weekly for 3 weeks in patients who have failed Revlimid but have adequate blood counts and renal function and minimal neuropathy. For study purposes, 1 cycle is considered to be 4 weeks (20 days). Subjects will get Abraxane for three weeks and will be off of this treatment for 1 week. There are 10 visits per cycle. Accrual will be on standard 3 patient cohorts. Once the maximum tolerated dose is reached, the level below will be expanded to 25 patients for a pilot phase II trial. All treatments will be performed until progression. Assessments will be made at least at the 2, 4, and 6 month timepoints and monthly thereafter until progression.

Since both drugs can cause myelosuppression, investigators will start with doses below their standard doses as single agents. Investigators will use 100 mg/m2 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. Dose de-escalations will also be performed for both drugs as necessary. Investigators will explore whether SPARC (secreted protein acidic and rich in cysteine) expression is altered by flow cytometry and immunohistochemistry.

Arms: arm 1: 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.
Interventions: intervention 1: Lenalidomide intervention 2: nab-paclitaxel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: