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Multiple MyelomaPhase 2RESTNCT04939844

REST - Replacing Steroids in the Transplant Ineligble

A Phase 2 study testing Isatuximab, bortezomib, lenalidomide, dexamethason in people with Multiple Myeloma, run by Oslo University Hospital at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Newly diagnosed multiple myeloma patients ineligible for HD-ASCT will be included in the study. All participants will receive isatuximab in combination with bortezomib, lenalidomide and minimal dexamethasone until disease progression. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Isatuximab, bortezomib, lenalidomide, dexamethason
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
4 sitesin 2 countries
Study dates
29 Jun 2021to 31 Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

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

Who may be able to join

  • Participants are eligible to be included in the study only if all of the following criteria apply:
  • Voluntary written informed consent.
  • Participant must be >18 years of age at the time of signing the informed consent.
  • Newly diagnosed multiple myeloma (IMWG criteria) in-eligible for high-dose therapy and ASCT.
  • Measurable disease as defined by the International Myeloma Working Group:
  • Serum monoclonal paraprotein (M-protein) level > 10 g/L or urine M-protein level >200 mg/24 hours; or
Show all 18Show fewer
  • Light chain multiple myeloma without measurable disease in the serum or the urine: Involved serum immunoglobulin FLC > 100 mg/L and abnormal serum immunoglobulin kappa lambda FLC ratio.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. ECOG 3 can only be enrolled if caused by myeloma.
  • Clinical laboratory values meeting the following criteria during the Screening Phase:
  • Adequate bone marrow function:
  • Hemoglobin >7,5 g/dL (transfusion is permitted, recombinant human EPO use is permitted, however transfusion is not permitted within 3 days before screening)
  • Absolute neutrophil count > 1.0 x 109/L (G-CSF use is permitted)
  • Platelet count >70 x 109/L
  • Adequate renal function:
  • eGFR>30 mL/min/m2
  • Patient must be willing and able to adhere to the study protocol visit schedule and other protocol requirements.
  • Females of childbearing potential (FCBPs) must have a confirmed negative serum or urine pregnancy test within 10-14 days prior to and again within 24 hours prior to starting study medication.
  • FCBPs and male subjects who are sexually active with FCBP must agree to use highly effective concomitant methods of contraceptive during the intervention period, for at least 5 months after last dose of isatuximab treatment and at least 28 days after last lenalidomide treatment. Male subjects must refrain from donating sperm during this period.

Who cannot join

  • Prior or current systemic therapy for multiple myeloma with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment.
  • Radiation therapy for treatment of plasmacytoma(s) within 14 days before treatment (local radiation for pain control or to prevent fracture is allowed within 14 days before treatment).
  • Active hepatitis B or C virus infection or known human immunodeficiency virus (HIV) positivity.
  • Any other serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
  • No active malignancy with a lower life expectancy than myeloma.
  • Female patients who are lactating or have a positive serum pregnancy test during the screening period.
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Norway3 sites

  • Oslo University Hospital

    Oslo

  • Helse Stavanger HF

    Stavanger

  • St. Olav University Hospital

    Trondheim

Other trials in Norway

Denmark1 site

  • Zealand University Hospital

    Roskilde, 4000

Other trials in Denmark

About this study

Official title: Isatuximab in Combination With Bortezomib and Lenalidomide With Minimal Dexamethasone in Transplant-ineligible Multiple Myeloma

Newly diagnosed multiple myeloma patients ineligible for HD-ASCT will be included in the study. All participants will receive isatuximab in combination with bortezomib, lenalidomide and minimal dexamethasone until disease progression. The primary objective of this study is the MRD negativity rate during and/or after first 18 cycles of study treatment.

Read the detailed description

Approximately 53 participants will be screened to achieve 50 enrolled (sample size) to study intervention.All participants will receive isatuximab in combination with bortezomib, lenalidomide and dexamethasone for 2 cycles, followed by isatuximab in combination with bortezomib and lenalidomide for 6 cycles, followed by isatuximab in combination with lenalidomide for 10 cycles, followed by continuous lenalidomide until disease progression. The cycle duration is 28 days.Bone marrow MRD Euroflow NGF will be assessed once in participants achieving CR/sCR during the first 18 cycles of treatment, and in all participants (except for those who already are defined as MRD negative) achieving VGPR or better after finishing the first 18 cycles of treatment to assess. Those who are in VGPR and are MRD negative after 18 cycles of treatment will be response evaluated monthly for up to 4 months and if they become >CR during this period they are defined as MRD negative. The cut-off for MRD negativity is 100 plasma cells per 100 million nucleated cells (10-5).

Being tested
Isatuximab, bortezomib, lenalidomide, dexamethason
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Isatuximab, bortezomib, lenalidomide, dexamethasonDrug

    All participants will receive the same treatment as described under arm.

Study groups in NCT04939844
Study groupRoleWhat they receive
NDMM ineligible for transplantExperimentalAll participants will receive isatuximab in combination with bortezomib, lenalidomide and dexamethasone for 2 cycles, followed by isatuximab in combination with bortezomib and lenalidomide for 6 cycles, followed by isatuximab in combination with lenalidomide for 10 cycles, followed by continuous lenalidomide until disease progression. The cycle duration is 28 days. * Isatuximab will be administered IV at a dose of 10 mg/kg * on D1, D8, D15 and D22 during Cycle 1 * on D1 and D15 during Cycles 2-18 * Bortezomib will be administered SC at a dose of 1,3mg/m2 -on D1, D8 and D15 during Cycles 1-8 * Lenalidomide will be administered PO at a dose of 25mg/day (15 mg/day in participants with GFR <30mL/minute/1.73m2) -on D1 to D21 during all Cycles. * Dexamethasone will be administered PO at a dose of 20 mg -on D1, D8, D15 and D22 during Cycles 1 and 2
Receives: Drug: Isatuximab, bortezomib, lenalidomide, dexamethason

What is being measured

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

  1. MRD negativity

    The proportion of patients who achieve MRD negativity measured by NGF Euroflow during and/or after 18 cycles of study treatment.

    Measured: 34 months

Secondary outcomes (3)

  1. Overall response rate

    The proportion of patients who achieve partial response (PR) or better following 18 cycles of study treatment

    Measured: 30 months

  2. Progression free survival

    The PFS rate of patients receiving 2 cycles of IVRd followed by 6 cycles of IVR, 10 cycles of IR and continuous R

    Measured: 4 years

  3. Overall survival

    The OS rate of patients receiving 2 cycles of IVRd followed by 6 cycles of IVR, 10 cycles of IR and continuous R.

    Measured: 5 years

Timeline

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

  1. First posted25 Jun 2021
  2. Study start29 Jun 2021
  3. Primary completion31 Aug 2024
  4. Study completion31 Aug 2024

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a Phase 2, investigator initiated, single arm, open-label, multicenter study of isatuximab in combination with bortezomib and lenalidomide (IVR) with minimal dexamethasone, in patients with newly diagnosed multiple myeloma (NDMM) in-eligible for high dose melphalan with autologous stem cell support (HD-ASCT).
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04939844
Sponsor's protocol ID
OMC02/20
Acronym
REST
Status last verified
Mar 2025
First submitted
7 Apr 2021
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Askeland FB, Haukas E, Slordahl TS, Klostergaard A, Alexandersen T, Lysen A, Abdollahi P, Nielsen LK, Hermansen E, Schjesvold F. Isatuximab, bortezomib, lenalidomide, and limited dexamethasone in patients with transplant-ineligible multiple myeloma (REST): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2025 Feb;12(2):e120-e127. doi: 10.1016/S2352-3026(24)00347-8.

    PubMed 39909655

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Isatuximab, bortezomib, lenalidomide, dexamethason in people with Multiple Myeloma, run by Oslo University Hospital at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Norway, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRD negativity (time frame: 34 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04939844, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.

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