A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse."

Study Purpose

This is a phase II, multicenter, open-label study to evaluate the rate of patients achieving very good partial response (VGPR) or better to the oral combination Iberdomide Ixazomib Dexamethasone in elderly patients with multiple myeloma at first relapse . The patient population will consist of adult men and women more than 70 years, who meet eligibility criteria. Following the screening period, patients will be enrolled and treated then, they will receive therapy with Iberdomide, Ixazomib and Dexaméthasone during 6 cycles and Iberdomide and Ixazomib until progression.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 70 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age > 70 years. 2. Eastern Collaborative Oncology Group (ECOG) performance score of ≤2. 3. Life expectancy > 6 months. 4. Voluntary written informed consent must be given before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care. 5. Symptomatic multiple myeloma (MM) at first relapse, as defined below:
  • - Symptomatic multiple myeloma according to international criteria.
(Rajkumar et al, 2014)
  • - Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy.
6. Subject must have received one prior line of therapy for at least 3 cycles. 7. Subject has measurable disease at Screening, defined at least one of the following:
  • - Serum M-protein ≥ 0.5 gram (g)/deciliter (dL), OR.
  • - Urine M-protein ≥ 200 mg in 24 hours, OR.
  • - Serum immunoglobulin free light chain (FLC) ≥ 10 mg/dL provided serum FLC ratio is abnormal.
8. Subjects must meet the following laboratory parameters, per laboratory reference range (performed at most 15 days before cycle 1 day 1):
  • - Absolute neutrophil count (ANC) ≥ 1000/microliter (μL).
Subjects may use growth factor support to achieve ANC eligibility criteria.
  • - Platelet count ≥ 75,000 /mm3 for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count ≥ 50,000/mm3 for subjects in whom > 50% of bone marrow nucleated cells are plasma cells.
It is not permissible to transfuse subjects to achieve minimum platelet counts within 3 days before study. --AST and ALT ≤ 3 × upper limit of normal (ULN).
  • - Total bilirubin ≤ 1.5 × ULN.
Subjects with documented Gilbert's syndrome may have bilirubin > 1.5 × ULN with the approval of the Primary Therapeutic Area Medical Director.
  • - Creatinine clearance (CrCl) ≥ 30 milliliter (mL)/minute (min) (using Cockroft and Gault Formula) 9.
Patient should comply with Celgene's pregnancy prevention plan for Iberdomide (please see appendix 8 Iberdomide Pregnancy Prevention Plan for subjects in clinical trials) 10. Female patients who:
  • - are postmenopausal for at least 24 months before the screnning visit, OR.
  • - are surgically sterile (have undergone a hysterectomy or bilateral oophorectomy) 11.
Men even if surgically sterilized must agree to not father a child and agree to practice complete abstinence or to use a condom during therapy and dose interruptions and for 90 days after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential or pregnant. Non-

inclusion Criteria:

1. Subject is refractory to bortezomib, defined as progression on or within 60 days of the last dose of bortezomib. 2. Subject has had prior treatment with ixazomib, carfilzomib, pomalidomide or iberdomide. 3. Subject has any of the following conditions:
  • - Non-secretory or oligo-secretory MM.
  • - Light chain Amyloidosis (AL Amyloidosis) - POEMS syndrome Waldenström macroglobulinemia.
4. Known Human Immunodeficiency Viral (HIV) infection. 5. Active hepatitis B or C infection based on blood screen tests. 6. Significant cardiovascular or pericardial disease, including uncontrolled angina, hypertension, arrhythmia, recent myocardial infarction within 6 months, congestive, heart failure New York Heart Association (NYHA) Class ≥ 3. 7. Major surgery within 4 weeks prior screening. 8. Acute infections requiring parenteral therapy (antibiotic, antifungal or antiviral) within 14 days. 9. ≥ Grade 3 Peripheral neuropathy or grade 2 with pain. 10. Uncontrolled diabetes or uncontrolled hypertension within 14 days. 11. Any other medical condition that, in the opinion of the Investigator, would adversely affect the subject's participation in the study. 12. Subject has a history of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry, with the following exceptions:
  • - Adequately treated in situ carcinoma of the cervix uteri or the breast, - Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, - Prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen (PSA) levels off treatment, - Previous malignancy with no evidence of disease confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study.
13. Known intolerance to steroid therapy. 14. Serious medical or psychiatric illness likely to interfere with participation in study. 15. Incidence of gastrointestinal disease that may significantly alter the absorption of oral drugs. 16. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment. 17. Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04998786
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Nantes University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Cyrille Touzeau
Principal Investigator Affiliation CHU de Nantes
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma at First Relapse
Arms & Interventions

Arms

Experimental: assessment of treatment Ixazomib, dexamethasone, iberdomide

Iberdomide, Ixazomib and Dexaméthasone during 6 cycles and Iberdomide and Ixazomib until progression

Interventions

Drug: - Ixazomib

Ixazomib 3 mg/day (days 1, 8, 15) cycle 1 to until progress

Drug: - Iberdomide

Iberdomide 1.6 mg / day (day 1 to 21) cycle 1 to until progress

Drug: - Dexamethasone Oral

Cycle 1 and 2 Dexaméthasone 20 mg/day on days 1, 8, 15, 22 Cycle 3 to 6 Dexamethasone 10 mg/day on days 1, 8, 15, 22

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHR, Annecy, France

Status

Recruiting

Address

CHR

Annecy, ,

Site Contact

Orsini-Piocelle

cyrille.touzeau@chu-nantes.fr

02.40.08.32.71

CH de la cote basque, Bayonne, France

Status

Recruiting

Address

CH de la cote basque

Bayonne, ,

CHRU Hopital Haut Lévêque, Bordeaux, France

Status

Not yet recruiting

Address

CHRU Hopital Haut Lévêque

Bordeaux, ,

CHU de Brest, Brest, France

Status

Not yet recruiting

Address

CHU de Brest

Brest, ,

CHU, Caen, France

Status

Recruiting

Address

CHU

Caen, ,

CHU, Clermont-Ferrand, France

Status

Not yet recruiting

Address

CHU

Clermont-Ferrand, ,

CHRU, Dijon, France

Status

Recruiting

Address

CHRU

Dijon, ,

CHD les Oudairies, La Roche-sur-Yon, France

Status

Recruiting

Address

CHD les Oudairies

La Roche-sur-Yon, ,

CHRU Lille, Lille, France

Status

Not yet recruiting

Address

CHRU Lille

Lille, ,

CHU, Limoges, France

Status

Not yet recruiting

Address

CHU

Limoges, ,

CH Lyon Sud, Lyon, France

Status

Not yet recruiting

Address

CH Lyon Sud

Lyon, ,

CHRU, Nancy, France

Status

Not yet recruiting

Address

CHRU

Nancy, ,

CHU, Nantes, France

Status

Recruiting

Address

CHU

Nantes, ,

Hopital de l'archet, Nice, France

Status

Not yet recruiting

Address

Hopital de l'archet

Nice, ,

CHU Henri Mondor, Paris, France

Status

Not yet recruiting

Address

CHU Henri Mondor

Paris, ,

Hopital St Antoine, Paris, France

Status

Not yet recruiting

Address

Hopital St Antoine

Paris, ,

Hopital St Louis APHP, Paris, France

Status

Not yet recruiting

Address

Hopital St Louis APHP

Paris, ,

University Hospital, Poitiers, France

Status

Not yet recruiting

Address

University Hospital

Poitiers, ,

CHRU, Rennes, France

Status

Not yet recruiting

Address

CHRU

Rennes, ,

ICANS, Strasbourg, France

Status

Not yet recruiting

Address

ICANS

Strasbourg, ,

Site Contact

Fohrer - Sonntag

cyrille.touzeau@chu-nantes.fr

02.40.08.32.71

CHU, Toulouse, France

Status

Not yet recruiting

Address

CHU

Toulouse, ,