Ruxolitinib

A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients

What's the purpose of the trial?

This is a phase 1, multicenter, open-label study evaluating the safety and efficacy of ruxolitinib, steroids and lenalidomide among multiple myeloma patients who currently show progressive disease.

Trial status

Accepting patients

Phase
Phase 1
Enrollment
134
Last Updated
2 months ago
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Participating Centers

There are 4 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

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  • Lenalidomide is an oral immunomodulatory drug that may help the immune system kill cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow.
  • Ruxolitinib is a tyrosine kinase inhibitor in development for the treatment of several different blood cancers.

Arms / Cohorts

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Accepting patients

Ruxolitinib + Lenalidomide + Steroids

Accepting patients

Ruxolitinib + Lenalidomide + Steroids

Accepting patients

Expanded Eligibility

Published Results

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Efficacy and Safety of Ruxolitinib and Steroids for Treating Patients with Relapsed or Refractory Multiple Myeloma

As of July 15, 2021, 27 patients were enrolled. The median age was 64 years (range, 46-85), and 17 (63%) were male. Patients received a median of 4 (range, 3-11) prior treatments including LEN and steroid-containing regimens to which they were all refractory. Twenty-six patients have completed at least 1 full cycle of therapy; and, thus, were evaluable for efficacy.

The ORR and CBR were 35% (n=9) and 39% (n=10), respectively. Notably, all 10 responding patients were refractory to LEN (i.e., progressed while on or within 8 weeks of last dosage). The remaining patients showed stable disease (n=12) or PD (n=4). The median follow-up was 13 months. The median progression-free survival was 4 months (range, 1-21). The median duration of response was 11 months (range, 1-20). Of 13 patients who progressed on the two-drug combination and had LEN added to their regimen, 6 patients responded (3 MR and 3 PR).

Nine patients experienced SAEs including sepsis (12%), sepsis with neutropenic fever (4%), thrombocytopenia (4%), hyperglycemia (4%), neutropenia (4%), anemia (4%), acute heart failure (4%), rotator cuff tear (4%), osteomyelitis (4%), aspiration pneumonia (4%), pneumonia and pneumothorax (4%), and deep venous thrombosis (4%). Two patients died (one each from pneumonia and PD).

2 years ago Read more

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