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Immunomodulatory Agent

Ruxolitinib + Steroids + Lenalidomide for Multiple Myeloma

Phase 1

Recruiting

Led By James R Berenson, MD

Research Sponsored by Oncotherapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previous exposure to lenalidomide independent of the response

Able to take aspirin (acetylsalicylic acid, ASA) at 81 or 325 mg/daily as antiplatelet therapy if platelet count is above 30 x 10E9/L

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 54 months

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective for treating multiple myeloma.

Who is the study for?

This trial is for Multiple Myeloma patients who've had the disease progress despite previous treatments and can't have a transplant. They should be able to perform daily activities with ease (ECOG ≤ 2), not be pregnant, sign consent forms, follow the study schedule, live more than 3 months, join REVLIMID REMS™ program, take aspirin if safe, and have measurable MM with certain lab results.Check my eligibility

What is being tested?

The study tests the combination of Ruxolitinib (Jakafi), steroids (Methylprednisolone), and Lenalidomide in those whose Multiple Myeloma has worsened. It's an early-stage trial to check how safe this mix is and how well it works against MM when other treatments haven't helped.See study design

What are the potential side effects?

Possible side effects include immune system suppression leading to infections, blood clots due to lenalidomide which requires aspirin use if platelets are sufficient; potential risks from steroids like increased blood sugar or bone weakening; and Jakafi might cause dizziness or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated with lenalidomide before.

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I can take aspirin daily and my platelet count is above 30 x 10E9/L.

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I have multiple myeloma with signs that can be measured.

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My multiple myeloma is getting worse.

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I have been diagnosed with multiple myeloma.

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I can take care of myself and am up and about more than half of my waking hours.

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I am not eligible for a transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 54 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~54 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 54 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determination of maximum tolerated dose (MTD) of ruxolitinib in combination with steroids and lenalidomide [Tolerability].

Incidence of Treatment-Emergent Adverse Events [Safety]

Secondary outcome measures

Assessment of response in additional cohorts

Assessment of the duration of response as a measure of efficacy (DOR)

Assessment of the overall survival (OS) as a measure of efficacy

+5 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Rux and Steroid until progression, then add LenExperimental Treatment3 Interventions

Subject will receive Ruxolitinib Oral Tablet [Jakafi] at 15mg BID, and Methylprednisolone at 40mg QOD until disease progression. Lenalidomide at 10mg QD will be added to the treatment (Ruxolitinib, Methylprednisolone) once disease progression was confirmed.

Group II: Rux Len and SteroidExperimental Treatment3 Interventions

Ruxolitinib Oral Tablet [Jakafi] at 5mg, 10mg or 15mg BID, Lenalidomide Oral at 5mg or 10mg QD and Methylprednisolone Oral at 40mg QOD. (Dose varies during dose escalation portion of the study)

Group III: High-dose RuxolitinibExperimental Treatment2 Interventions

Subject will receive Ruxolitinib Oral Tablet [Jakafi] at 20mg BID and Methylprednisolone at 40mg QOD until disease progression.

Group IV: Expanded Eligibility CriteriaExperimental Treatment3 Interventions

Subject will receive Ruxolitinib Oral Tablet [Jakafi] at 15mg BID, Lenalidomide at 10mg QD, and Methylprednisolone at 40mg QOD until disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~1480

Methylprednisolone

2015

Completed Phase 4

~2280

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationIndustry Sponsor

364 Previous Clinical Trials

55,031 Total Patients Enrolled

7 Trials studying Multiple Myeloma

325 Patients Enrolled for Multiple Myeloma

OncotherapeuticsLead Sponsor

22 Previous Clinical Trials

809 Total Patients Enrolled

21 Trials studying Multiple Myeloma

786 Patients Enrolled for Multiple Myeloma

James R Berenson, MDPrincipal InvestigatorOncotherapeutics

8 Previous Clinical Trials

284 Total Patients Enrolled

8 Trials studying Multiple Myeloma

284 Patients Enrolled for Multiple Myeloma

Media Library

Multiple Myeloma Research Study Groups: Expanded Eligibility Criteria, High-dose Ruxolitinib, Rux Len and Steroid, Rux and Steroid until progression, then add Len

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health conditions are typically treated with Lenalidomide?

"Lenalidomide is often prescribed for ophthalmia, sympathetic and other conditions like scalp structure, prior systemic chemotherapy regimens, and multiple sclerosis."

Answered by AI

Is this investigation being conducted in multiple U.S.-based facilities?

"This trial is running out of 8 clinics, including those located in Alhambra, Bethesda and West Hills. To reduce the burden of transportation for participants, it may be prudent to select the closest clinic when enrolling."

Answered by AI

What goals is the research team hoping to achieve from this trial?

"The trial's sponsor, Oncotherapeutics, has outlined the primary outcome as a 30-month assessment of Treatment-Emergent Adverse Events. As secondary outcomes to measure efficacy, they are assessing Duration of Response (defined as time from first response to progressive disease), Time to Response (time from initiation of therapy to evidence of confirmed clinical benefit) and Overall Survival rates."

Answered by AI

How many individuals are being treated with this clinical experimentation?

"For this trial to be a success, 134 participants fitting the inclusion criteria must be enlisted. The sponsor Oncotherapeutics has set up operations in multiple places such as Global Oncology, Inc. (Alhambra, Maryland) and Regional Cancer Care Associates (RCCA) MD, LLC (Bethesda Florida)."

Answered by AI

What potential risks may be associated with the use of Lenalidomide?

"Due to limited clinical data regarding both its efficacy and safety, Lenalidomide received a score of 1."

Answered by AI

Is there currently an enrollment period for this clinical experiment?

"Affirmative. Information on clinicaltrials.gov attests that this medical investigation, which was first displayed on February 1st 2017, is presently recruiting participants. A total of 134 subjects need to be enlisted from 8 different sites."

Answered by AI

Are there any other past endeavors utilizing Lenalidomide to inform current practices?

"As of now, 506 studies involving lenalidomide are ongoing with 106 clinical trials in their third phase. While many labs focus on the medication is based in Duarte, California, a total of 22318 spots around the country are running research into this drug."

Answered by AI

Recent research and studies

Clinical Cancer ResearchJournal

A Phase I Study of Ruxolitinib, Lenalidomide, and Steroids for Patients with Relapsed/refractory Multiple Myeloma

Berenson, James R., Jennifer To, Tanya M. Spektor, Daisy Martinez, Carley Turner, Armando Sanchez, Matthew Ghermezi, et al.. 2020. “A Phase I Study of Ruxolitinib, Lenalidomide, and Steroids for Patients with Relapsed/refractory Multiple Myeloma”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-19-1899.

Hematological OncologyJournal

A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/refractory Multiple Myeloma Patients

Berenson, James R., Clara Kim, Sean Bujarski, Jennifer To, Tanya M. Spektor, Daisy Martinez, Carley Turner, et al.. 2022. “A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/refractory Multiple Myeloma Patients”. Hematological Oncology. Wiley. doi:10.1002/hon.3066.

clinicaltrials.govStudy

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

2017. "A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03110822.

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