The Norwegian Immunotherapy in Multiple Myeloma Study

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: Patients with multiple myeloma, plasma cell leukemia or AL amyloidosis treated at study sites outside clinical trials.

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: The Norwegian Immunotherapy in Multiple Myeloma Study - A Population-based Longitudinal Observational Multicenter Study on Effectiveness and Complications of Immunotherapy in Multiple Myeloma in the Norwegian Myeloma Cohort

Conditions

Myeloma Multiple, Plasma Cell Leukemia, AL Amyloidosis

Being tested

Teclistamab, Elranatamab, Ciltacabtagene Autoleucel, Talquetamab, Idecabtagene vicleucel

Keywords

bispesific antibodies, teclistamab, elranatamab, talquetamab, cilta-cel, ide-cel, ciltacabtagene autoleucel, idecabtagene vicleucel, CRS, ICAN, infections, supportive care

Medical subject headings

Multiple Myeloma, Leukemia, Plasma Cell, Immunoglobulin Light-chain Amyloidosis, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• TeclistamabDrug

  Real-world use and dosing

• ElranatamabDrug

  Real-world use and dosing

• Ciltacabtagene AutoleucelBiological

  Real-world use.

• TalquetamabDrug

  Real-world use and dosing

• Idecabtagene vicleucelBiological

  Real-world use and dosing

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Determine the real-world overall response rates (ORR)

   Measured: From date of treatment start and until date of first documented progression or start of next line of therapy, whichever came first, assessed up to ten years.

2. Determine real-world progression-free survival (PFS)

   Measured: From date of treatment start and until date of first documented progression or death, whichever came first, , assessed up to ten years.

3. Determine real-world time-to-next treatment (TTNT)

   Measured: From date of treatment start and until date of start of next treatment, assessed up to ten years.

4. Determine real-world overall survival (OS)

   Measured: From date of treatment start and until death, assessed up to ten years.

5. Describe the frequency and grading of adverse events of special interest (AESI), defined as described below.

   • Cytokine release syndrome (CRS) (ASTCT grade 1-5),
   • Infections (CTCAE grade 1-5)
   • Neurological adverse events (including, but not limited to, ICANS, peripheral sensory and/or motor neuropathy, neurocognitive and hypokinetic movement disorder) (CTCAE 5.0. grade 1-5).
   • Immune effector cell-associated hematotoxicity (ICAHT) (EHA/EBMT Consensus Grading 1-4)27
   • Secondary malignancies, dysgeusia, skin- and nail adverse events, pain, hemophagocytic lymphohistiocytosis (HLH) and tumor lysis syndrome (CTCAE grade 1-5)

   Measured: From date of treatment start until the date of start of next line of treatment or death, whichever came first, assessed up to 10 years

6. Frequency and grading of all other adverse events occurring during treatment according to CTCAE 5.0 (only grade 3 or higher will be reported).

   Measured: From start of treatment and until start of next treatment or death, assessed up to ten years.

7. Describe the microbiological pattern (positive cultures/PCR) of infections during treatment.

   Measured: From start of treatment and start of next treatment line or death, assessed up to ten years.

8. Describe the antibiotic resistance pattern of positive cultures.

   Measured: From start of treatment and start of next treatment line or death, assessed up to ten years.

9. Describe the prevalence of common airway viruses during treatment and at end-of-treatment.

   Measured: From date of start of treatment and until end of treatment, assessed up to ten years.

10. Determine the real-world use of antimicrobial prophylaxis (antibiotics, antivirals, vaccines, immunoglobulines) before and during therapy.

    Measured: From enrollment and until end of treatment, assessed up to ten years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted3 Mar 2025
2. Study start15 Jan 2025
3. Primary completionJan 2029 (estimated)
4. Study completion1 Dec 2037 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Myeloma MultipleStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.