Study of Iberdomide in People With Multiple Myeloma Who Have Had an Autologous Hematopoietic Stem Cell Transplant (AHCT)

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05354557
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Iberdomide — DRUG
    Patients will receive 12 cycles of iberdomide as maintenance therapy. Cohort 1: Cycle 1-12: Iberdomide 1mg daily Days 1-21 of 28 day cycles Cohort 2: Cycles 1-12: Iberdomide 1mg daily Days 1-21 of 28 day cycles

Study Details

The purpose of this study is to see if iberdomide is a safe and effective maintenance therapy option for people with Multiple Myeloma (MM) who have had an Autologous Hematopoietic Stem Cell Transplant (AHCT) and have already had lenalidomide as maintenance therapy. Patients will receive iberdomide treatment beyond 12 months if they continue to derive benefit from the treatment and will continue until progression of disease or unacceptable toxicity. Follow-up will be as per standard of care for a patient on maintenance therapy, and patients will not require additional research samples.

Key Dates

Start date
Apr 26, 2022
Status verified
May 2026
Primary completion
Apr 26, 2027
Completion
Apr 26, 2027

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Single prior autoHCT with melphalan
    Participants have not experienced disease progression since initiation of initial systemic anti-myeloma therapy, are within 12 months of frontline autoHCT with \>/=140mg/m2 of melphalan, initiated lenalidomide maintenance at least 6 months ago, and have a very good partial response (VGPR) or less at time of enrollment. Cohort 1 will be initiated after evaluation of preliminary efficacy and safety data from Cohort 2.
  • Experimental: 2 to 3 prior lines of systemic anti-myeloma therapy +/- prior autoHCT
    Participants have already received lenalidomide maintenance after a prior line of treatment, underwent a salvage autoHCT within the prior 2-6 months as consolidation therapy for relapsed disease after 2 to 3 prior therapies

Primary Outcome Measure

Complete response (CR) rate [ Time Frame: 6 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Consent and Followup)Basking RidgeNew Jersey07920-
Memorial Sloan Kettering Monmouth (Consent and Follow-Up only)MiddletownNew Jersey07748-
Memorial Sloan Kettering Bergen (Consent and Follow up)MontvaleNew Jersey07645-
Memorial Sloan Kettering Suffolk-Commack (Consent and Follow up)CommackNew York11725-
Memorial Sloan Kettering Westchester (Consent and Follow Up)HarrisonNew York10604-
Memorial Sloan Kettering Cancer Center (All protocol activities)New YorkNew York10065-
Weill Cornell Medical College (Data Collection Only)New YorkNew York10021-
Memorial Sloan Kettering Nassau (Consent and Followup)Rockville CentreNew York11553-

Find similar trials in Basking Ridge, NJ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Memorial Sloan Kettering Basking Ridge (Consent and Followup)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Consent and Follow-Up only)· Middletown, NJMemorial Sloan Kettering Bergen (Consent and Follow up)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (Consent and Follow up)· Commack, NYMemorial Sloan Kettering Westchester (Consent and Follow Up)· Harrison, NYMemorial Sloan Kettering Cancer Center (All protocol activities)· New York, NY

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