Trial Title:
Iberdomide and Daratumumab as Maintenance Therapy After an Autologous Stem Cell Transplant for Multiple Myeloma
NCT ID:
NCT06107738
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Daratumumab
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Iberdomide
Description:
Iberdomide 1.0mg daily for days 1-21 of a 28-day cycle, an increase to 1.3 mg daily on
Day 1-21 of a 28-day cycle is allowed at cycle 4 or higher if the 1.0 mg dose was well
tolerated.
Arm group label:
Iberdomide and Daratumumab
Other name:
CC220
Intervention type:
Drug
Intervention name:
Daratumumab/rHuPH20 Co-formulation
Description:
Daratumumab/rHuPH20 will be dosed as follows:
- Daratumumab/rHuPH20 1800 mg SC days 1, 8, 15, 22 (28-day cycle; cycles 1-2)
- Daratumumab/rHuPH20 1800 mg SC days 1, 15 (28-day cycle; cycles 3-6)
- Daratumumab/rHuPH20 1800 mg SC day 1 (28-day cycle; cycles 7-26)
Arm group label:
Iberdomide and Daratumumab
Other name:
Darzalex FASPRO
Other name:
Daratumumab and Hyaluronidase-fihj
Summary:
The goal of this phase 2 clinical trial is to learn if patients with Multiple Myeloma who
are minimal residual disease positive after initial therapy (including an autologous stem
cell transplant [ASCT]) will benefit from maintenance therapy with Iberdomide and
subcutaneous (SC) Daratumumab. The main questions it aims to answer are:
- Assess if giving Iberdomide and the SC Daratumumab in the maintenance setting is an
effective treatment and warrants further investigation in patients with residual
disease
- Is giving Iberdomide and SC Daratumumab maintenance post ASCT a safe option
Participants will:
- provide informed consent and complete screening assessments for eligibility within
28 days of starting treatment
- Screening assessments include specific laboratory tests, a medical history
assessment and a physical examination (including temperature, pulse, blood pressure,
respirations, height and weight), an assessment of your heart function, a breathing
test, cancer imaging, a bone marrow biopsy, minimal residual disease testing (MRD)
and a questionnaire
- If eligible, patients will start treatment with Iberdomide (1.0 mg on day 1-21 of
each 28 day cycle, with an increase to 1.3 mg on Cycle 4 if the 1.0 mg dose was
tolerated, to a maximum of 26 cycles or progressive disease, whichever is first) and
SC Daratumumab (1800 mg SC on days 1, 8, 15 and 22 of cycle 1 and 2, then 1800 mg SC
on Day 1 and 15 of cycle 3-6 and 1800 mg SC on Day 1 for cycles 7-26 to a maximum of
26 cycles or progressive disease, whichever is first)
- while receiving treatment on study, physical exams (including temperature, pulse,
blood pressure, respirations, height and weight), toxicity assessments, laboratory
assessments and questionnaires will be done at various times over the course of the
26 cycles
- an MRD assessment is required at 6, 12 and 24 months after starting treatment
- End of treatment will occur once 26 cycles are completed, or cancer has progressed
whichever comes first. At that time, specific laboratory tests, a physical
examination (including temperature, pulse, blood pressure, respirations, height and
weight), cancer imaging, a bone marrow biopsy and minimal residual disease testing
(MRD) will occur.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Multiple Myeloma patients who have received prior DARA-containing induction therapy
and have attained at least a partial response.
2. Patients who have completed Autologous Stem Cell Transplant (ASCT) 90-150 days prior
to registration, without any post-ASCT therapy and without post-ASCT disease
progression (according to IMWG criteria)
3. Patients who are Minimal Residual Disease positive (MRD (+)) as measured by the
ClonoSEQ assay using a sensitivity of 10-5, measured 90-150 days following ASCT.
4. Prior DARA-containing induction therapy (at least 3 cycles), attaining at least a
partial response.
5. Completed ASCT within 90-150 days prior to registration, without any post-ASCT
therapy and without evidence of post-ASCT disease progression (according to IMWG
criteria)
6. MRD (+) at the time of study enrollment using the clonoSEQ NGS (next-generation
sequencing) assay. Patients with an M-spike of ≥ 0.5 g/dL and/or an abnormal free
light chain ratio (with an involved serum free light chain of ≥ 10 mg/dL) at
enrollment are considered MRD (+) and do not require baseline MRD testing if they
have previously had this testing done with successful clonality assessment.
7. ECOG (Eastern Cooperative Oncology Group) Performance Status /= 75,000/mm3, hemoglobin
>/= 8 g/dL, and ANC (absolute neutrophil count) >/= 1,000/mm3 within 28 days prior
to registration. NOTE: transfusion to achieve the hemoglobin threshold IS
permissible.
9. Adequate hepatic function defined by the following within 28 days prior to
registration: total bilirubin /= 30 mL/min.,
as measured by a 24-hour urine collection or estimated by the Cockcroft and Gault
formula within 28 days prior to registration.
11. All ASCT-related toxicities must have recovered to 470 msec
using Fridericia's QT correction formula.
17. Use of strong inhibitors or inducers of CYP3A4, P-gp, or BCRP for at least 14 days
or 5 half-lives (whichever is shorter) prior to initiating protocol therapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christiane Houde
Phone:
313-576-8673
Email:
Houdec@karmanos.org
Investigator:
Last name:
Jeffery Zonder, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Suresh Balasubramanian, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Abhinav Deol, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Indryas L Woldie, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Andrew Kin, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Dipenkumar Modi, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Lois Ayash, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Melissa Runge Morris, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Vijendra Singh, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Joesph Uberti, M.D. PhD
Email:
Sub-Investigator
Investigator:
Last name:
Jay Yang, M.D.
Email:
Sub-Investigator
Start date:
December 21, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Barbara Ann Karmanos Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Collaborator:
Agency:
Janssen Pharmaceuticals
Agency class:
Industry
Collaborator:
Agency:
Multiple Myeloma Research Consortium
Agency class:
Other
Source:
Barbara Ann Karmanos Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06107738
