NCT03110822

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

Recruiting now Phase 1 Last updated 30 October 2023

What this trial tests

Phase 1 trial testing Ruxolitinib Oral Tablet [Jakafi] in Multiple Myeloma in 134 participants. Currently enrolling.

Timeline

1 February 2017

Primary endpoint
1 September 2024

1 February 2027

Quick facts

Lead sponsor	Oncotherapeutics
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	134
Start date	1 February 2017
Primary completion	1 September 2024
Estimated completion	1 February 2027
Sites	13 locations across United States

Drugs / interventions tested

• Ruxolitinib Oral Tablet [Jakafi] — full drug profile →
• Lenalidomide — full drug profile →
• Methylprednisolone (methylprednisolone) — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Oncotherapeutics — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Determination of maximum tolerated dose (MTD) of ruxolitinib in combination with steroids and lenalidomide [Tolerability].
  Time frame: 30 months
  MTD will be determined by measuring incidence of the dose-limiting toxicities (DLTs) per dose level, of ruxolitinib in combination with steroids and lenalidomide for MM patients currently with progressive disease.
• Incidence of Treatment-Emergent Adverse Events [Safety]
  Time frame: 54 months
  Safety will be measured by counting the occurrence of adverse events throughout the study, graded via Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 criteria

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. JAK-STAT signaling in human disease: From genetic syndromes to clinical inhibition.
   Luo Y, Alexander M, Gadina M, O'Shea JJ, et al · · 2021 · cited 92× · PMID 34625141 · DOI 10.1016/j.jaci.2021.08.004
2. STAT3 Activation and Oncogenesis in Lymphoma.
   Zhu F, Wang KB, Rui L. · · 2019 · cited 55× · PMID 31861597 · DOI 10.3390/cancers12010019
3. Multiple myeloma: signaling pathways and targeted therapy.
   Lu Q, Yang D, Li H, Niu T, et al · · 2024 · cited 50× · PMID 38961036 · DOI 10.1186/s43556-024-00188-w
4. A Phase I Study of Ruxolitinib, Lenalidomide, and Steroids for Patients with Relapsed/Refractory Multiple Myeloma.
   Berenson JR, To J, Spektor TM, Martinez D, et al · · 2020 · cited 25× · PMID 31937615 · DOI 10.1158/1078-0432.ccr-19-1899
5. Novel Agents in Multiple Myeloma.
   Szalat R, Munshi NC. · · 2019 · cited 21× · PMID 30694859 · DOI 10.1097/ppo.0000000000000355
6. Biological Hallmarks and Emerging Strategies to Target STAT3 Signaling in Multiple Myeloma.
   Zhou J, Chng WJ. · · 2022 · cited 13× · PMID 35326392 · DOI 10.3390/cells11060941
7. Current Status of Novel Agents for the Treatment of B Cell Malignancies: What's Coming Next?
   Tannoury M, Garnier D, Susin SA, Bauvois B. · · 2022 · cited 10× · PMID 36551511 · DOI 10.3390/cancers14246026
8. A phase 1 study of ruxolitinib, steroids and lenalidomide for relapsed/refractory multiple myeloma patients.
   Berenson JR, Kim C, Bujarski S, To J, et al · · 2022 · cited 8× · PMID 35946431 · DOI 10.1002/hon.3066