Trial Title:
Elotuzumab + Iberdomide + Dexamethasone Post Ide-Cel in RRMM
NCT ID:
NCT06518551
Condition:
Myeloma
Multiple Myeloma
Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Elotuzumab
Conditions: Keywords:
Myeloma
Multiple Myeloma
Refractory Multiple Myeloma
Relapsed Multiple Myeloma
Relapsed and Refractory Multiple Myeloma
MM
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Elotuzumab
Description:
Humanized, recombinant IgG1 monoclonal antibody, 400- and 300-mg single-use vials, via
intravenous (into the vein) infusion per protocol.
Arm group label:
Phase 1: Dose Escalation
Arm group label:
Phase 2: Dose Expansion
Other name:
BMS-901608
Intervention type:
Drug
Intervention name:
Iberdomide
Description:
A cereblon E3 ligase modulator, 0.15mg, 0.2mg, 0.3mg, 0.45mg, 0.6, and 0.75 mg strength
capsule taken orally per protocol.
Arm group label:
Phase 1: Dose Escalation
Arm group label:
Phase 2: Dose Expansion
Other name:
CC-220
Other name:
Iberdomide hydrochloride
Other name:
C25H28N3O5Cl
Other name:
BMS-986382
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Synthetic adrenocortical steroid, 2 and 4 mg tablets, taken orally per standard of care.
Arm group label:
Phase 1: Dose Escalation
Arm group label:
Phase 2: Dose Expansion
Other name:
Decadron
Other name:
9- fluoro11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione
Summary:
The aim of this research study is to evaluate the efficacy of Elotuzumab and Iberdomide
therapy post-Idecabtagene Vicleucel in participants with relapsed and refractory multiple
myeloma.
The names of the study drugs involved in this study are:
- Iberdomide (a type of cereblon E3 ligase modulator)
- Elotuzumab (a type of monoclonal antibody)
- Dexamethasone (a type of steroid)
Detailed description:
This is a phase I/II, open-label, non-randomized, single-stage study to evaluate the
efficacy of Elotuzumab and Iberdomide therapy post-Idecabtagene Vicleucel in participants
with relapsed and refractory multiple myeloma. Iberdomide has demonstrated some antitumor
activity in laboratory studies.
The U.S. Food and Drug Administration (FDA) has approved Elotuzumab as a treatment option
for Multiple Myeloma. Dexamethasone, also FDA approved, is a type of steroid and is
usually combined with other chemotherapy for the treatment of blood cancers, such as
myeloma and leukemias. The U.S. Food and Drug Administration (FDA) has not approved
Iberdomide as a treatment for Multiple Myeloma.
The research study procedures include screening for eligibility, study treatment visits,
bone marrow biopsies, blood and urine tests, electrocardiograms (ECGs), X-rays, and
Positron Emission Tomography (PET) scans, Computerized Tomography (CT) scans, or Magnetic
Resonance Imaging (MRI) scans.
It is expected about 49 people will take part in this research study.
Bristol-Myers Squibb and Celgene, a BMS company, are supporting this research study by
providing study drug and providing funding for the trial.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Previously diagnosed with MM based on standard IMWG criteria
- Patient has given voluntary written informed consent before any study-related
procedures not part of normal medical care are performed, with the understanding
that consent may be withdrawn by the patient at any time without prejudice to their
future medical care.
- Patient who has been treated with at least 4 prior lines of anti-myeloma treatment
including immunomodulating agent, a proteasome inhibitor, and an anti-CD38
monoclonal antibody.
- In addition, to at least 4 prior lines of anti-myeloma treatment, patient has
received ide-cel in accordance with the FDA approved US Prescribing Information and
has achieved at least a partial response, and is within 90 days of infusion
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Screening Laboratory evaluations within the following parameters
- Absolute neutrophil count (ANC) ≥ 1,000 cells/dL (1.0 x 109/L) (Growth factors
cannot be used more recently than 7 days prior to initiation of therapy)
- Platelet count ≥ 75,000 cells/dL (75 x 109/L) (without transfusions during the
7 days prior to initiation of therapy)
- Hemoglobin ≥ 8.0 g/dL (RBC transfusions are permitted)
- Total Bilirubin ≤ 1.5 X upper limit of normal (ULN) (except subjects with
Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
- AST or ALT ≤ 3x ULN
- Creatinine clearance ≥ 30 ml/min according to the Cockroft-Gault formula:
- Female CrCl = [(140 - age in years) x weight in kg x 0.85] / [72 x serum
creatinine in mg/dL]
- Male CrCl = [(140 - age in years) x weight in kg x 1.00] / [72 x serum
creatinine in mg/dL]
- Age ≥18 years.
- Ability to understand and the willingness to sign a written informed consent
document.
- A Female of childbearing potential (FCBP) must:
- Have two negative pregnancy tests before enrollment and randomization into the
clinical studies and prior to each re-supply of study drug during the clinical
studies based on the frequency outlined in the Pregnancy Prevention Plan (PPP,
Appendix D).
- Sexually active FCBP must agree to use protocol-specified contraceptive methods
during participation in the clinical studies and for at least 28 days after the
last dose of study drug.
- Sexually active males (including those who have had a vasectomy) must agree to use
protocol specified contraceptive methods during participation in the clinical
studies and for at least 28 days after the last dose of study drug.
- All participants (male and female with or without childbearing potential) must agree
to abstain from donating blood products for at least 28 days after the last dose of
study drug and semen or sperm while taking study drug and for at least 28 days after
the last dose of study drug.
Exclusion Criteria
- Prior exposure to Iberdomide
- Participation in other clinical trials, including those with other investigational
agents not included in this trial, within 30 days of the start of this trial and
throughout the duration of this trial.
- Diagnosed or treated for another malignancy within 3 years prior to enrollment, with
the exception of complete resection of basal cell carcinoma or squamous cell
carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after
curative therapy
- Known central nervous system involvement.
- Systemic treatment, within 14 days before the first dose of treatment, with strong
CYP3A or inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin,
phenobarbital), or use of St. John's wort OR systemic treatment within 14 days of
the first dose of treatment with a strong inhibitor of CYP1A2 (ciprofloxacin,
fluvoxamine, cimetidine, enoxacin, ethynyl estradiol, mexiletine)
- Any medical or psychiatric illness/social situation that in the Investigator's
opinion, would impose excessive risk to the patient, would adversely affect his/her
participating in this study or would limit compliance with study requirements.
- Currently active graft versus host disease of any stage or grade after allogeneic
stem cell transplantation
- Prior major surgical procedure or radiation therapy within 14 days of initiation of
therapy.
- Those who require a limited course of radiation for management of bone pain
more than 14 days out from initiation of therapy are not excluded
- Any active, or uncontrolled cardiovascular conditions, including but not limited to
uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive
heart failure, unstable angina, grade 3 thromboembolic event or myocardial
infarction within the past 6 months.
- The following therapies within the stated time frames prior to initiation of
therapy:
- Previous cytotoxic therapies, including cytotoxic investigational agents, for
multiple myeloma within 21 days (42 days for nitrosoureas).
- The use of live vaccines within 30 days.
- IMiDs or proteasome inhibitors within 14 days.
- Other investigational therapies and/or monoclonal antibodies within 4 weeks.
- Prior peripheral stem cell transplant within 12 weeks.
- Prior allogeneic stem cell transplantation with active
graft-versus-host-disease.
- Those who require a limited course of daily requirement for corticosteroids
(equivalent to >10 mg/day prednisone, though >10mg/day is acceptable if
physiological levels require, so long as the dose is stable for at least 7 days
prior to initiation of therapy. Inhalation corticosteroids are exempt from this
criterion.
- Lower amounts of corticosteroids that are not part of a daily requirement
within 14 days prior to initiating therapy
- Concurrent symptomatic amyloidosis or plasma cell leukemia
- POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein and skin changes)
- Infection requiring systemic antibiotic therapy or other serious infection within 7
days of starting therapy.
- Those who are on prophylactic antibiotics only, or on antibiotics and have
confirmation of resolution of active infection are eligible.
- Known seropositive for active viral infection with human immunodeficiency virus
(HIV) hepatitis B (HBV) or hepatitis C viral (HCV). Those who are seropositive
because of hepatitis B vaccine are eligible. Patients who are positive for HBV core
antibody or HBV surface antigen must have a negative polymerase chain reaction (PCR)
result prior to enrollment. Those who are PCR positive will be excluded
- Female patients who are pregnant or lactating.
- Participants who are receiving any other investigational agents for any indication
- History of erythema multiforme or severe hypersensitivity to prior IMiD's® or those
who have a known allergy to any of the study medications, their analogues, or
excipients in the various formulations of any agent.
- Inability to tolerate thromboprophylaxis
- Failure to have fully recovered (≤ Grade 2 according to CTCAE v 5) from the
reversible effects of prior chemotherapy
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Contact:
Last name:
Omar Nadeem, MD
Phone:
617-632-4703
Email:
Omar_Nadeem@dfci.harvard.edu
Contact backup:
Last name:
Omar Nadeem, MD
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Contact:
Last name:
David Avigan, MD
Phone:
617-667-9920
Email:
davigan@bidmc.harvard.edu
Contact backup:
Last name:
David Avigan, MD
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Start date:
November 1, 2024
Completion date:
December 31, 2034
Lead sponsor:
Agency:
Omar Nadeem, MD
Agency class:
Other
Collaborator:
Agency:
Celgene
Agency class:
Industry
Collaborator:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06518551
