NCT05354557

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2 multiple-myeloma

Timeline
11mo left

Started Apr 2022

Typical duration for phase_2 multiple-myeloma

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Apr 2022Apr 2027

First Submitted

Initial submission to the registry

April 26, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2027

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

5 years

First QC Date

April 26, 2022

Last Update Submit

May 14, 2026

Conditions

Multiple Myeloma

Keywords

multiple myelomaAutologous Hematopoietic Stem Cell TransplantStem Cell TransplantAHCTIberdomide22-040Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • Complete response (CR) rate

    Estimate the 6-month complete response (CR) rate after iberdomide in Multiple Myeloma patients with suboptimal disease responses after an autoHCT and lenalidomide maintenance or autoHCT performed in patients who had progressed on lenalidomide maintenance previously.

    6 months

Study Arms (2)

Single prior autoHCT with melphalan

EXPERIMENTAL

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.

Drug: Iberdomide

2 to 3 prior lines of systemic anti-myeloma therapy +/- prior autoHCT

EXPERIMENTAL

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

Drug: Iberdomide

Interventions

IberdomideDRUG

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

2 to 3 prior lines of systemic anti-myeloma therapy +/- prior autoHCTSingle prior autoHCT with melphalan

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All Patients
  • Histologic confirmation of multiple myeloma by the enrolling institution. Cohort specific eligibility below.
  • Age 18-75
  • Karnofsky performance greater than or equal to 70.
  • Recovered to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding Grade 2 neuropathy.
  • Laboratory criteria
  • Absolute neutrophil count (ANC) greater than or equal to 1,000/mm3 without filgrastim use in the prior 14 days.
  • Platelet count greater than 75,000/mm3 (without platelet transfusion in the previous 7 days or thrombopoietin mimetics in the previous 28 days)
  • Hemoglobin greater than 8 g/dL (without red blood cell transfusion in the previous 7 days)
  • Creatinine Clearance (CrCl) greater than or equal to 30 mL/min, measured or estimated by Cockcroft-Gault equation.
  • Corrected serum calcium less than or equal to 13.5 mg/dL
  • Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than or equal to 2.5 x upper limit of normal (ULN)
  • Serum total bilirubin less than or equal to 2 x ULN. Patients who have been diagnosed with Gilbert's disease are permitted to exceed the defined bilirubin value of 2 x ULN
  • International ratio (INR) or partial thromboplastin time (PTT) less than 1.5 x ULN unless on therapeutic anticoagulation
  • Females of childbearing potential (defined below) have a negative serum pregnancy test with a sensitivity of at least 50 mIU/mL
  • +23 more criteria

You may not qualify if:

  • Prior allogeneic hematopoietic stem cell transplant
  • Disease progression after most recent autoHCT prior to enrollment
  • Known active central nervous system (CNS) involvement with MM
  • Prior organ transplant requiring systemic immunosuppressive therapy
  • History of a thromboembolic event while on full anticoagulation during prior therapy with an immunomodulatory agent (IMiD)
  • Unwilling to take DVT prophylaxis while on iberdomide maintenance
  • History of greater than or equal to Grade 2 hemorrhage within 30 days of enrollment
  • History of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis
  • Ongoing treatment with chronic immunosuppressants (eg, cyclosporine or systemic steroids at any dose). Physiologic replacement, intermittent topical, inhaled or intranasal corticosteroids are allowed.
  • Seropositive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B (defined as positive hepatitis B surface antigen (HepBSAg) or Hepatitis B core antibody (HepBcore Ab)) or C (Hep C Ab), or acute hepatitis A. If any history of exposure to hepatitis B or C, then PCR should be negative.
  • Prior malignancies except resected basal cell carcinoma or treated carcinoma in situ.
  • Cancer treated with curative intent less than 5 years prior to enrollment will not be allowed unless approved by the MSK PI. Cancer treated with curative intent greater than 5 years prior to enrollment is allowed.
  • Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or pomalidomide
  • Uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.
  • Serious medical of psychiatric illness likely to interfere with participation on this clinical study
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Memorial Sloan Kettering Basking Ridge (Consent and Followup)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Consent and Follow-Up only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent and Follow up)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Suffolk-Commack (Consent and Follow up)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Consent and Follow Up)

Harrison, New York, 10604, United States

Location

Weill Cornell Medical College (Data Collection Only)

New York, New York, 10021, United States

Location

Memorial Sloan Kettering Cancer Center (All protocol activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Consent and Followup)

Rockville Centre, New York, 11553, United States

Location

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

iberdomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Gunjan Shaw, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2022

First Posted

April 29, 2022

Study Start

April 26, 2022

Primary Completion (Estimated)

April 26, 2027

Study Completion (Estimated)

April 26, 2027

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(8)