Actively Recruiting
A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-06
26
Participants Needed
7
Research Sites
182 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to find out whether the combination of elranatamab and cyclophosphamide is an effective treatment for people with relapsed/refractory multiple myeloma (MM) who have risk factors that may affect how well their disease would respond to elranatamab alone.
CONDITIONS
Official Title
A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Pathologically confirmed diagnosis of multiple myeloma according to 2014 IMWG criteria
- Measurable disease by serum M-protein ≥0.5 g/dL, serum free light chain ≥10 mg/dL with abnormal kappa to lambda ratio, urinary M-protein ≥200 mg/24 hours, bone marrow plasma cells ≥30%, or myeloma bone or plasmacytoma lesion ≥2 cm
- At least one adverse risk feature including extramedullary myeloma detected by PET/CT, serum beta-2-microglobulin level ≥5.5 mg/dL, or bone marrow plasma cells ≥50%
- Received at least one prior therapy line for multiple myeloma including at least one immunomodulatory drug, one proteasome inhibitor, and one anti-CD38 monoclonal antibody
- ECOG Performance Status 0 to 2
- Not pregnant or nursing and agree to use contraception during and for 6 months after treatment
- Adequate blood counts: absolute neutrophil count ≥1,000/mm3, platelets ≥25,000/mm3, hemoglobin ≥8 g/dL
- Adequate kidney function with creatinine clearance ≥15 mL/min
- Adequate liver function with total bilirubin ≤1.5 times upper limit of normal and AST/ALT ≤3 times upper limit of normal
- Adequate cardiac function with clinical risk assessment if history or symptoms of heart disease
You will not qualify if you...
- Previous treatment with CD3 redirecting bispecific or trispecific antibodies for multiple myeloma
- Diagnosis of plasma cell leukemia, smoldering multiple myeloma, Waldenström's macroglobulinemia, amyloidosis, or POEMS syndrome
- Active central nervous system involvement or signs of myelomatous meningeal involvement
- Autologous stem cell transplant within 8 weeks before enrollment
- Active graft-versus-host disease or allogeneic stem cell transplant within 12 weeks before enrollment
- Significant cardiovascular disease within 6 months including recent heart attack, unstable angina, cardiac arrhythmias, decompensated heart failure worse than NYHA class 2B, thromboembolic or cerebrovascular events, or prolonged QT syndrome
- Active or uncontrolled infections including bacterial, HIV (unless healthy and low risk), hepatitis B or C without proper control, or COVID-19 infection
- Other active cancers within 2 years except certain skin cancers or low-risk neoplasms
- History of Guillain-Barré syndrome or severe peripheral motor polyneuropathy
- History of organ transplant requiring immunosuppressive therapy
- Gastrointestinal conditions affecting absorption of cyclophosphamide
- Major surgery within 14 days before enrollment
- Recent or active suicidal thoughts or behavior, or other medical or psychiatric conditions increasing study risk
- History of anaphylaxis or severe allergy to cyclophosphamide
- Receipt of live attenuated vaccine within 4 weeks before first study dose
- High dose corticosteroids equivalent to prednisone ≥140 mg within 14 days before first study dose
- Unable or unwilling to follow required infection prevention measures
- Recent use of investigational products within 28 days or 5 half-lives before first study dose unless in follow-up phase and approved by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
A
Alexander Lesokhin, MD
CONTACT
C
Carlyn Rose Tan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here