A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma

Study on Investigational Medication and Dexamethasone (a Steroid) for Relapsed/Refractory Multiple Myeloma

A
Attaya Suvannasankha, MD

Primary Investigator

Recruiting
18 years - 100 years
All
Phase 2
3 participants needed
2 Locations

Brief description of study

The purpose of this Phase 2 study is to assess the antimyeloma activity and further characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cemsidomide in combination with dexamethasone in subjects with relapsed/refractory multiple myeloma (r/r MM).

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

Study Design This is a Phase 2, open-label, single-arm, multicenter study to evaluate
the efficacy, safety, PK, and PD of cemsidomide in combination with
dexamethasone in subjects with r/r MM. The study consists of the
following defined time periods (refer to Table 1):
• Screening Period: Screening assessments must be completed
within 28 days prior to Cycle 1 Day 1 (C1D1).
• Treatment Period: Subjects will receive cemsidomide plus
dexamethasone during a treatment cycle (1 cycle = 28 days)
and will continue to receive treatment until the subject meets
one of the discontinuation criteria (Section 7.2.1).
• End of Treatment (EOT) Visit: Should occur within 21 days of
discontinuing study treatment if not completed during a
regularly scheduled visit where discontinuation decision was
made.
• Safety Follow-up Visit: Should occur within 30 to 35 days after
the last dose of study treatment.
• Disease Progression Follow-Up Period: If a subject
discontinues study treatment without evidence of disease
progression, the subject will continue to be followed every 4
weeks (Q4W) until disease progression, death, withdrawal of
consent for study participation, lost to follow-up (LTFU), or
end of study, whichever occurs first.
• Survival Follow-Up Period: All subjects after end of treatment
will be followed for survival every 3 months for at least 12
months from C1D1 regardless of whether they progress or start
a subsequent anticancer therapy.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Relapsed/Refractory Multiple Myeloma, Cancer
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
Subjects eligible for inclusion in this study must meet all the following criteria:
1. Be willing and able to provide signed informed consent for the study.
2. Age ≥18 years at the time of signed consent.
3. ECOG Performance Status ≤2.
4. Subjects must have a documented diagnosis of MM and measurable disease at
enrollment. Measurable disease is defined as follows:
• Serum M-protein by sPEP ≥0.5 g/dL
• Serum dFLC >10 mg/dL with an abnormal kappa/lambda (κ/λ) ratio (1.65)
• Urine M-protein by uPEP ≥200 mg/24-hour urine
5. For prior treatments, subjects must have the following:
• Received at least 3 prior antimyeloma regimens (for a minimum of 2 or more
consecutive cycles) that must have included an immunomodulatory drug (i.e.,
IKZF1/3 degrader), a proteasome inhibitor, an anti-CD38 antibody, and a TCE or
CAR-T therapy, unless not indicated and/or patient refusal.
• Refractory to or had documented disease progression within 60 days from the last
dose of their prior MM treatment (or, if the last MM therapy was with CAR-T cells,
documented disease progression any time after administration).
6. Subjects must be able to provide a BMA and/or BMB during screening or use an archival
sample (within 6 months of screening visit) for chromosomal abnormalities (FISH)
(Section 8.2.2).
7. Subjects need to have adequate organ function defined as follows:
• ANC ≥1.0 × 109/L assessed at least 5 days after receiving G-CSF, and after at least
10 days after receiving pegfilgrastim.
• Platelets ≥75,000 cells/μL at least 5 days after receiving a platelet transfusion or use
of platelet-stimulating drugs (e.g., romiplostim or eltrombopag).
• Hemoglobin ≥8.0 g/dL independent of transfusion support for at least 7 days after
blood transfusion or use of erythropoietin.
• ALT and AST ≤3.0 × ULN; except for subjects who have tumor infiltration of the
liver, where ALT or AST ≤5 × ULN.
• Total bilirubin ≤1.5 × ULN (unless due to Gilbert’s syndrome; total bilirubin should
be ≤3.0 × ULN).
• CrCl ≥40 mL/min (Cockcroft-Gault equation, or per institutional standard, or directly
measured).
• Corrected serum calcium ≤13.5 mg/dL (≤3.5 mmol/L).
• INR must be on a stable regimen and have INR and aPTT within the therapeutic range for
the anticoagulant regimen).
8. Toxicities from prior anticancer therapies must have resolved to baseline severity or
CTCAE Grade ≤1.
9. Female subjects may not be pregnant or intend to become pregnant, may not breastfeed
or intend to breastfeed, or donate ova during their participation in this study until 30 days
after the last dose of study treatment, must agree to the pregnancy testing and highly
effective contraception requirements of the study (Section 11.2).
• Subjects of childbearing potential must agree to use highly effective contraception, as
defined in Section 11.2, during their participation in the study until 30 days after the
completion of study treatment.
• Subjects on HRT and whose menopausal status is in doubt will be required to use one
of the contraception methods (per Section 11.2) specified if they wish to continue
their HRT during the study.
• Subjects of nonchildbearing potential (i.e., physiologically incapable of becoming
pregnant), defined as (a) premenopausal female with documented history of bilateral
salpingo-oophorectomy or hysterectomy; (b) postmenopausal female, defined as
12 months of spontaneous amenorrhea without an alternative medical cause which
can be confirmed in questionable cases, by a serum FSH >40 MIU/ML.
10. Male subjects must agree to use a condom when having intercourse with a person of
childbearing potential during the Treatment Period and for at least 30 days after the last
dose of study treatment.
11. Male subjects must refrain from donating sperm during the Treatment Period and for
30 days after discontinuation.
12. Subjects must refrain from donating blood during study treatment and for 30 days after
discontinuation.

Exclusion Criteria
Subjects eligible for this study must not meet any of the following criteria:
1. Presence of myeloma in the CNS.
2. Has received prior plasmapheresis and/or radiotherapy within 2 weeks of start of study
treatment.
3. Subjects with any of the following:
• Nonsecretory or oligosecretory MM
• Systemic light chain amyloidosis
• Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin
changes (POEMS) Syndrome
• MDS
4. Treatment with mezigdomide or iberdomide during the subject’s most recent line of
therapy.
5. Previously treated with cemsidomide.
6. Peripheral neuropathy ≥Grade 2 at screening.
7. Clinically significant impaired cardiac function or cardiac disease, including the
following:
• LVEF • Clinically significant and/or uncontrolled heart disease such as congestive heart
failure requiring treatment (NYHA ≥Grade 2), uncontrolled hypertension, or
clinically significant arrhythmia.
• Average QTcF >480 msec on screening ECG (for subjects with pacemakers or bundle
branch block that distort the QT interval, consult the sponsor medical monitor).
• Acute myocardial infarction or unstable angina pectoris within 6 months prior to
study entry.
8. Thromboembolic event within 3 months prior to enrollment. Enrolled subjects must have
a risk-based prophylaxis for venous thromboembolism as described in Section 6.2.1.4.
9. Known malignancy other than study indication that has progressed or required treatment
within the past 3 years. A history of localized or noninvasive cancers such as basal or
squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast carcinoma, cervical
cancer in situ) may be acceptable and must be approved by the sponsor.
10. Major surgery within 2 weeks of the first dose of study treatment.
11. Received live, attenuated vaccine within 4 weeks of first dose.
12. Known history of HIV infection.
13. Any subject with a known history of, or considered at risk for, Hepatitis B infection must
be tested. Subjects will be excluded if HBsAg is detected. If a subject has undetectable
HBsAg but has detectable HBc and anti-HBsAg antibodies, they may be enrolled if
serum hepatitis B DNA is undetectable by a PCR-based assay.
14. Any subject with a known history or risk of HCV must test negative for anti-HCV
antibodies. If anti-HCV antibodies are present or there is a prior history of HCV
treatment, HCV RNA must be undetectable.
15. Any active, uncontrolled bacterial, fungal, or viral infection (including pneumonitis) or
any life-threatening illness, medical condition, or organ system dysfunction which, in the
investigator’s opinion, could compromise the subject’s safety or put the study outcomes
at undue risk.
16. Concurrent administration of strong CYP3A inducers or inhibitors, including certain
foods, and inhibitors of P-gp and BCRP. Strong CYP3A inhibitors and inhibitors of P-gp
and BCRP must be discontinued 5 half-lives before the first dose of study drug, and
strong CYP3A inducers must be discontinued 14 days prior to the first dose of study drug
(Section 6.4.3).
Note: If a subject can be switched to a similar agent that is not a strong CYP3A
modulator or is a weak CYP3A modulator they may be permitted to enroll in the study.
17. Patient has received prior treatment for MM (approved or investigational) ≤5 half-lives or
4 weeks (whichever is shorter) prior to the first dose of study treatment.
18. Inability or difficulty swallowing tablets, malabsorption syndrome, or any disease or
medical condition significantly affecting gastrointestinal function.
19. Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound results of the study, interfere with the subject’s participation for full
duration of the study, or is not in the best interest of the subject to participate, in the
opinion of the treating investigator.
20. Has a known psychiatric or substance abuse disorder that would interfere with
cooperating with requirements of the study.
21. Previously identified hypersensitivity to components of the study treatment or excipients.  

This study investigates the effects of an investigational medication combined with dexamethasone on people with relapsed or refractory multiple myeloma. Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow, which are important for the immune system. This condition can cause symptoms like bone pain, fatigue, and frequent infections.

Participants in the study will receive the investigational medication along with dexamethasone. The study will include different periods such as screening, treatment, and follow-up. During the treatment period, participants will take the medication in cycles, each lasting 28 days, until they meet certain criteria for stopping the treatment. Follow-up visits will help monitor their safety and any changes in their condition.

  • Who can participate: Adults aged 18 and older with relapsed or refractory multiple myeloma who have had at least three prior treatments including specific drug types may be eligible. Participants must have a measurable disease and meet certain health criteria.
  • Study details: Participants will take part in various stages of the study, including treatment cycles with the investigational medication and dexamethasone. A placebo is not used in this study.
Updated on 30 Jul 2026. Study ID: CTO-CFT7455-2101, 29939

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