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New treatment option for Multiple Myeloma
Official title Iberdomide and Daratumumab as Maintenance Therapy After an Autologous Stem Cell Transplant for Multiple Myeloma
ClinicalTrials.gov ID: NCT06107738
What this study is testing
What is Iberdomide?
Iberdomide is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for multiple myeloma.
Also referred to as CC220.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Multiple Myeloma patients who have received prior DARA-containing induction therapy and have attained at least a partial response.
- Patients who have completed Autologous Stem Cell Transplant (ASCT) 90-150 days prior to registration, without any post-ASCT therapy and without...
- Patients who are Minimal Residual Disease positive (MRD (+)) as measured by the ClonoSEQ assay using a sensitivity of 10-5, measured 90-150 days...
- Prior DARA-containing induction therapy (at least 3 cycles), attaining at least a partial response.
- Completed ASCT within 90-150 days prior to registration, without any post-ASCT therapy and without evidence of post-ASCT disease progression...
You likely can't join if
- Active HIV, or HCV (defined as detectable viremia for any of these conditions).
- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen[HBsAg]). Patients with resolved infection (i.e., patients...
- Unable to assess MRD status at entry or is MRD(-) at 10-5 threshold at entry
- Heart attack or stroke within 90 days of study enrollment
- Unable to tolerate required anti-thrombotic or anti-viral prophylaxis
- Major surgery within 28 days of enrollment
See the full eligibility criteria
Who can join
- Multiple Myeloma patients who have received prior DARA-containing induction therapy and have attained at least a partial response.
- 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)
- 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.
- Prior DARA-containing induction therapy (at least 3 cycles), attaining at least a partial response.
- 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)
- 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...
- ECOG (Eastern Cooperative Oncology Group) Performance Status \</= 2
- Adequate bone marrow function as evidenced by platelets \>/= 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...
- Adequate hepatic function defined by the following within 28 days prior to registration: total bilirubin \</=1.5 x IULN (institutional upper limit of the norm, except in case of Gilbert's syndrome) AND AST (aspartate...
- Adequate renal function, as defined by creatinine clearance (CrCl) \>/= 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.
- All ASCT-related toxicities must have recovered to \</=Grade 1 (except for alopecia, fatigue and amenorrhea) prior to registration
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU (milli-International unit)/mL within 10-14 days prior to registration. FCBP must agree to...
- Men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy, during the study treatment and for 90 days after the last dose of study treatment. They must also...
- Must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
- Age 18 yrs. old or greater
What rules you out
- Active HIV, or HCV (defined as detectable viremia for any of these conditions).
- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen[HBsAg]). Patients with resolved infection (i.e., patients who are HBsAg negative but positive for antibodies to hepatitis B core...
- Unable to assess MRD status at entry or is MRD(-) at 10-5 threshold at entry
- Heart attack or stroke within 90 days of study enrollment
- Unable to tolerate required anti-thrombotic or anti-viral prophylaxis
- Major surgery within 28 days of enrollment
- Medical, neurologic, or psychiatric condition which renders patient unable to safely comply with study therapy and schedule requirements (including, but not limited to, unstable angina, New York Heart Association Class...
- Intolerance of prior DARA therapy (requiring discontinuation of DARA previously due to toxicity)
- A history of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease before the date of enrollment...
- Be exhibiting clinical signs of meningeal or central nervous system involvement due to multiple myeloma.
- Have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal.
- Have known moderate or severe persistent asthma within the past 2 years (see Section 9.2.4), or current uncontrolled asthma of any classification. Note that patients who currently have controlled intermittent asthma or...
- Have any of the following:
- Myocardial infarction within 6 months of enrollment, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association...
- Uncontrolled cardiac arrhythmia
- Have known allergies, hypersensitivity, or intolerance to boron or mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to the IB) or known sensitivity to...
- Be pregnant, or breast-feeding, or planning to become pregnant or breast-feed while enrolled in this study or within 90 days after the last dose of study treatment(s). Or, if male, planning to father a child while...
- Prolongation of QT interval on screening ECG as defined by a QTc interval \> 470 msec using Fridericia's QT correction formula.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
- Lansing, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States; Lansing, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.