Optimise viewing for

Toggle between patient and health professional views. The patient version is simplified to help people easily find suitable trials, while the professional view provides full detail.

RecruitingLast updated: 22 May 2026

CERVINO: This study is assessing a medicine called ABBV-383 compared to standard available therapies in people with relapsed or refractory multiple myelomaA Phase 3, Multicenter, Randomized, Open Label Study of ABBV-383 Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

CERVINO

Clinical summary

Summary

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment.

About this study

This is a study to determine change in disease symptoms of a medicine called ABBV-383 compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R MM.

Eligible participants will be randomly allocated to one of two treatment arms. 

In Arm A, participants will receive ABBV-383 as an infusion into the vein (via IV) in 28 day cycles, during the 3.5 year study duration.

In Arm B, participants will receive the standard available therapy identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable during the 3.5 year study duration.

Standard available therapy choices are:

  • carfilzomib + dexamethasone (Kd)
  • elotuzumab + pomalidomide + dexamethaone (EloPd)
  • selinexor + bortezomib + dexamethasone (SVd).

Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Conditions

This trial is treating people with relapsed or refractory multiple myeloma

Eligibility

Inclusion

Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
* Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
* Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:

* Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
* Urine M-protein \>= 200 mg/24 hours.
* In participants without measurable serum or urine M protein, serum free light chain (FLC) \>= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
* Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).
* Must be naïve to treatment with B-cell maturation antigen (BCMA)-targeted therapy.
* Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.

Exclusion

Exclusion Criteria:

* Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
* Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
* Central nervous system involvement of MM.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

+ Show non-recruiting hospitals

No longer recruiting (closed or complete) hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AbbVie

Scientific Title

A Phase 3, Multicenter, Randomized, Open Label Study of ABBV-383 Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

Get Support

Peer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Know more about Peer Connect

Contact cancer support

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.

Get support

Multilingual information

Learn more about clinical trials through this collection of resources in languages other than English.

View information