Relapsed or Refractory Multiple Myeloma Clinical Trial
Official title:
Phase I/II Trial of the Combination of Lenalidomide (Revlimid) and Nab-paclitaxel (Abraxane) in the Treatment of Relapsed/Refractory Multiple Myeloma
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.
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.
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