COMbination Regimens in MM Post AHCT to elimiNate MRD Utilizing IbERdomide (NCT05434689) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
COMbination Regimens in MM Post AHCT to elimiNate MRD Utilizing IbERdomide
United States80 participantsStarted 2023-01-18
Plain-language summary
Similar to the paradigm established in other hematologic malignancies that are considered curable, the achievement of MRD(-) status is necessary for long term disease control in MM. The fact that the majority of patients remain MRD (+) after induction therapy and AHCT points to the opportunity to deploy novel agents with complementary mechanism of action and favorable toxicity profile to reach and maintain MRD (-) status.
Given its favorable toxicity profile, the convenience of oral administration, and compelling single agent activity even in heavily pretreated MM, iberdomide is likely amenable to long term therapy in patients with high-risk of relapse/progression identified by the persistence of MRD(+). The investigators intend to develop combination(s) of iberdomide with other agents with complementary mechanism of action in the consolidation setting post AHCT in order to achieve and sustain MRD (-).
Who can participate
Age range19 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age \>18 years with no upper age limit
✓. Confirmation of newly diagnosed multiple myeloma (MM) with 1-2 prior regimens utilized in induction that included an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI) combined or in different regimens
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
✓. Prior AHCT 100-180 days prior to initiation of protocol-directed therapy
✓. MRD ≥ 10\^-5 by clonoSEQ® NGS platform, determined 60-120 days after AHCT as part of the usual care.
✓. No prior disease progression (either before or since AHCT)
✓. Overall response (i.e post-AHCT compared to historical baseline prior to initiation of any therapy for MM) ≥ PR.
✓. Measurable disease at the time of the initial diagnosis (i.e. prior to starting any therapy for MM) meeting at least one of the following criteria:
Exclusion criteria
✕
What they're measuring
1
Dose limiting toxicity
Timeframe: One year
2
MRD conversion ( to < 10-5 MM-associated molecules)
. Diagnosis of amyloidosis, POEMS, Waldenstrom's macroglobulinemia, plasma cell leukemia or smoldering multiple myeloma (i.e. never evolved to active myeloma).
✕. Major surgery or radiotherapy within 28 days of starting protocol-directed treatment.
✕. Acute active infection requiring treatment within 14 days of starting protocol-directed treatment.
✕. Current or prior involvement of central nervous system by multiple myeloma.
✕. MM refractory to prior CD38 monoclonal antibody therapy and/or to carfilzomib (prior exposure allowed). Refractoriness here is defined as not achieving at least a PR in a regimen containing the agent or disease progression \< 60 days from last dose of the agent.
✕. Pregnant or lactating females.
✕. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
✕. Seropositive for hepatitis C (except in the setting of a sustained virologic response \[SVR\], defined as aviremia at least 12 weeks after completion of antiviral therapy).