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

Part of paid clinical trials in Alhambra, California.

Sponsor
Oncotherapeutics
Study ID
NCT03110822
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib Oral Tablet [Jakafi] — DRUG
    Ruxolitinib will be administered on days 1-28 of the treatment cycle.
  • Lenalidomide — DRUG
    Lenalidomide will be administered on Days 1-21 of the treatment cycle.
  • Methylprednisolone — DRUG
    Methyl-prednisolone will be administered on Days 1-28 of the treatment cycle.

Study Details

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.

Key Dates

Start date
Feb 1, 2017
Status verified
Oct 2023
Primary completion
Sep 30, 2024
Completion
Feb 28, 2027

Study Design

Enrollment
134 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Rux Len and Steroid
    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)
  • Experimental: Rux and Steroid until progression, then add Len
    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.
  • Experimental: Expanded Eligibility Criteria
    Subject will receive Ruxolitinib Oral Tablet \[Jakafi\] at 15mg BID, Lenalidomide at 10mg QD, and Methylprednisolone at 40mg QOD until disease progression.
  • Experimental: High-dose Ruxolitinib
    Subject will receive Ruxolitinib Oral Tablet \[Jakafi\] at 20mg BID and Methylprednisolone at 40mg QOD until disease progression.

Primary Outcome Measure

Determination of maximum tolerated dose (MTD) of ruxolitinib in combination with steroids and lenalidomide [Tolerability]. [ Time Frame: 30 months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Global Oncology, Inc.AlhambraCalifornia91801
Kirsten Bettino
[email protected]
Honghao Yang, MD (PRINCIPAL_INVESTIGATOR)
Comprehensive Blood and Cancer CenterBakersfieldCalifornia93309-0633-
California Cancer Associates for Research & Excellence (cCARE)EncinitasCalifornia92024
Christina Spencer
[email protected]
760-452-3909
Mona Bilawa
[email protected]
Alberto Bessudo, MD (PRINCIPAL_INVESTIGATOR)
Compassionate Care Research Group, Inc.Fountain ValleyCalifornia92708-
Robert A. Moss, M.D., F.A.C.P., Inc.Fountain ValleyCalifornia92708-
Pacific Cancer CareMontereyCalifornia93940-
Sansum Clinic- Ridley-Tree Cancer CenterSanta BarbaraCalifornia93105-
Wellness Oncology and HematologyWest HillsCalifornia91307
Anna Herrera
[email protected]
Karla De Santiago
[email protected]
Ashkan Lashkari, MD (PRINCIPAL_INVESTIGATOR)
James R. Berenson M.D. Inc.West HollywoodCalifornia90069
Regina Swift, R.N
[email protected]
310-623-1227
James R Berenson, MD (PRINCIPAL_INVESTIGATOR)
Cancer Specialists, LLCJacksonvilleFlorida32256
Mary A Anderson
[email protected]
Amanda Fallon
[email protected]
Mehdi M Moezi, MD (PRINCIPAL_INVESTIGATOR)
Millennium Oncology Research ClinicPembroke PinesFlorida33024-
Regional Cancer Care Associates (RCCA) MD, LLCBethesdaMaryland20817-
Northwest Medical Specialists, PPLCTacomaWashington98405-

Find similar trials in Alhambra, CA

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Global Oncology, Inc.· Alhambra, CAComprehensive Blood and Cancer Center· Bakersfield, CACalifornia Cancer Associates for Research & Excellence (cCARE)· Encinitas, CACompassionate Care Research Group, Inc.· Fountain Valley, CARobert A. Moss, M.D., F.A.C.P., Inc.· Fountain Valley, CAPacific Cancer Care· Monterey, CA

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