Actively Recruiting
A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients
Led by Oncotherapeutics · Updated on 2023-11-01
134
Participants Needed
13
Research Sites
521 weeks
Total Duration
On this page
Sponsors
O
Oncotherapeutics
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of multiple myeloma confirmed by either two major criteria or a combination of major and minor criteria as defined by tissue biopsy, bone marrow plasmacytosis, and monoclonal immunoglobulin levels
- Measurable multiple myeloma disease with specific levels of monoclonal immunoglobulin or light chains in serum or urine
- Currently has progressive multiple myeloma
- Has relapsed or refractory disease after at least two prior treatments including an immunomodulatory drug and a proteasome inhibitor
- Previous exposure to lenalidomide regardless of response
- Not a candidate for stem cell transplant
- Able to understand and sign informed consent
- Able to adhere to study visit schedule and protocol requirements
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy greater than 3 months
- Laboratory test results within specified ranges for neutrophils, platelets, hemoglobin, kidney and liver function, and potassium
- Registered in the REVLIMID REMS program and willing to comply with its requirements
- Female participants of childbearing potential must have negative pregnancy tests and agree to contraception requirements
- Able to take aspirin or alternative anticoagulant therapy if platelet count is above 30 x 10E9/L
You will not qualify if you...
- Diagnosis of POEMS syndrome
- Plasma cell leukemia with more than 2 x 10E9/L circulating plasma cells
- Primary amyloidosis
- Non-hematologic malignancy within the past 5 years except certain treated or low-risk cancers
- Significant heart disease including recent heart attack, heart failure, uncontrolled angina, pericardial disease, severe arrhythmias, or low heart function
- Severe high blood calcium levels
- Serious medical, psychiatric, or laboratory conditions preventing informed consent or increasing risk
- Major surgery within 28 days prior to enrollment or incomplete recovery from such surgery
- Pregnant or breastfeeding females
- Recent chemotherapy, corticosteroids over 20 mg prednisone equivalent, immunotherapy, antibody therapy, or certain drug treatments within defined timeframes prior to study
- Known allergy to thalidomide, lenalidomide, or steroids
- Current use of other anti-cancer treatments
- History of erythema nodosum with desquamating rash from thalidomide or similar drugs
- Known HIV, hepatitis B or C infection, or active or latent tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Global Oncology, Inc.
Alhambra, California, United States, 91801
Actively Recruiting
2
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309-0633
Active, Not Recruiting
3
California Cancer Associates for Research & Excellence (cCARE)
Encinitas, California, United States, 92024
Actively Recruiting
4
Compassionate Care Research Group, Inc.
Fountain Valley, California, United States, 92708
Terminated
5
Robert A. Moss, M.D., F.A.C.P., Inc.
Fountain Valley, California, United States, 92708
Terminated
6
Pacific Cancer Care
Monterey, California, United States, 93940
Terminated
7
Sansum Clinic- Ridley-Tree Cancer Center
Santa Barbara, California, United States, 93105
Terminated
8
Wellness Oncology and Hematology
West Hills, California, United States, 91307
Actively Recruiting
9
James R. Berenson M.D. Inc.
West Hollywood, California, United States, 90069
Actively Recruiting
10
Cancer Specialists, LLC
Jacksonville, Florida, United States, 32256
Actively Recruiting
11
Millennium Oncology Research Clinic
Pembroke Pines, Florida, United States, 33024
Terminated
12
Regional Cancer Care Associates (RCCA) MD, LLC
Bethesda, Maryland, United States, 20817
Active, Not Recruiting
13
Northwest Medical Specialists, PPLC
Tacoma, Washington, United States, 98405
Withdrawn
Research Team
J
James R Berenson, MD
CONTACT
A
Afra Yehwalashet
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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