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RecruitingLast updated: 15 February 2024

VIBER-M: This study aims to assess the effect of a combination therapy with Venetoclax, Iberdomide and Dexamethasone for the treatment of patients with first or second relapse of Multiple Myeloma t(11;14)A phase 1b/II study of the efficacy of Venetoclax, Iberdomide and Dexamethasone (IberVenD) for patients in first or second relapse of Multiple Myeloma with t(11;14)

Clinical summary

Summary

Eligible participants will receive cycles of combination treatment. Each cycle is 28 days in length.

The treatment is the following 3 products that will be used in combination:

  • Venetoclax, an oral treatment that participants will take from Day 1 to Day 28 of each cycle.
  • Iberdomide, an oral treatment that participants will take from Day 1 to Day 21.
  • Dexamethasone, which participants will likely have had before. This will be taken on Days 1, 8, 15, and 22.

Participants will continue on the treatment until they are no longer responding to the therapy, or if the treatment causes too many adverse events.

It is hoped this research will determine whether the combination of Venetoclax, Iberdomide and Dexamethasone is successful at treating people with relapsed or refractory multiple myeloma.

Conditions

This trial is treating patients with relapsed or refractory multiple myeloma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

Trial Acronym

VIBER-M

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • ALLG MM25

Trial sponsor

Australasian Leukaemia & Lymphoma Group

Scientific Title

A phase 1b/II study of the efficacy of Venetoclax, Iberdomide and Dexamethasone (IberVenD) for patients in first or second relapse of Multiple Myeloma with t(11;14)

Eligibility

Inclusion

 

1. Males or females, age 18 years or older, capable of giving consent
2. ECOG performance status of 0 to 2.
3. Have confirmed MM as defined by IMWG criteria and have had 1 to 2 prior lines of therapy
4. Have measurable disease defined by having at least one of the following:
o Serum M-protein concentration of greater than or equal to 5g/L
o Urine M-protein excretion of greater than or equal to 200mg/24 hours
o Involved serum free light chain (SFLC) greater than or equal to 100mg/L and an abnormal SFLC ratio ( less than 0.26 or
greater than 1.65)
5. Positive for t(11;14) by fluorescence-in-situ-hybridisation (FISH) testing on bone marrow aspirate sample
6. Adequate bone marrow function
7. Adequate liver function (ALT/AST equal to 2.5 x Upper limit of normal, Bilirubin equal to 1.5 x Upper limit of normal)
8. Adequate renal function (creatinine clearance equal to 30ml/minute)
9. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following applies
o Is not a woman of childbearing potential (WOCBP) or
o Is a WOCBP and is using a contraceptive method that is highly effective (with failure rate of less than 1%/year) during the study intervention and for at least 4 months after the last dose of the study drug
10. A male participant is eligible to participate if they agree to refrain from donating sperm AND either agree to be abstinent from heterosexual intercourse or agree to use barrier contraception when engaging in sexual activity with a WOCBP (including pregnant females). This female partner must also be using an additional method of highly effective contraceptive method (with failure rate of less than 1%/year).
11. Willing and able to comply with all study requirements, including treatment (e.g. able to swallow tablets), timing and/or nature of required assessments
12. Signed, written informed consent

Exclusion

1. Previous treatment with Bcl-2 inhibitor or CELMod
2. Any of the following conditions: Non-secretory Multiple Myeloma, solitary plasmacytoma or plasma cell leukaemia.
3. Known Central nervous system involvement
4. Systemic anti-myeloma therapy within less than or equal to 14 days with the exception of corticosteroids equivalent to dexamethasone less than or equal to 160mg in total within last 4 weeks.
5. Major surgery within 14 days of initiating study treatment
6. Radiotherapy within 14 days of initiating study treatment
7. Female patients who are lactating or have a positive serum pregnancy test during screening period.
8. Evidence of cardiovascular risk:
o Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block;
o History of myocardial infarction, acute coronary syndrome (including unstable angina), coronary angioplasty, or stenting or bypass grafting within the last 6 months;
o Class III of IV heart failure defined by New York Heart Association functional classification system
9. Known immediate or delayed hypersensitivity or allergy to previous drugs chemically related to venetoclax and/or Iberdomide.
10. Acute infections requiring antibiotic, antifungal or antiviral therapy within 1 week prior to first dose.
11. Known HIV infection.
12. Hepatitis B surface antigen positivity or Hepatitis B DNA positivity at screening or within 3 months prior to first dose of study treatment. Participants with positive Hepatitis B core antibody testing can be enrolled if Hepatitis B DNA negative and receiving Hepatitis B prophylaxis.
13. Known gastrointestinal disease or procedure that could interfere with the oral absorption or tolerance of iberdomide or venetoclax.
14. Use of a strong or moderate CYP3A inhibitor or inducer within 1 week prior to starting first dose of study treatment.
15. Diagnosed or treated for another malignancy within 2 years before study enrolment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
16. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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