REST - Replacing Steroids in the Transplant Ineligble (REST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04939844|
Recruitment Status : Active, not recruiting
First Posted : June 25, 2021
Last Update Posted : March 1, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Isatuximab, bortezomib, lenalidomide, dexamethason||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||Isatuximab in Combination With Bortezomib and Lenalidomide With Minimal Dexamethasone in Transplant-ineligible Multiple Myeloma|
|Actual Study Start Date :||June 29, 2021|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||October 2026|
Experimental: NDMM ineligible for transplant
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.
Drug: Isatuximab, bortezomib, lenalidomide, dexamethason
All participants will receive the same treatment as described under arm.
- MRD negativity [ Time Frame: 34 months ]The proportion of patients who achieve MRD negativity measured by NGF Euroflow during and/or after 18 cycles of study treatment.
- Overall response rate [ Time Frame: 30 months ]The proportion of patients who achieve partial response (PR) or better following 18 cycles of study treatment
- Progression free survival [ Time Frame: 4 years ]The PFS rate of patients receiving 2 cycles of IVRd followed by 6 cycles of IVR, 10 cycles of IR and continuous R
- Overall survival [ Time Frame: 5 years ]The OS rate of patients receiving 2 cycles of IVRd followed by 6 cycles of IVR, 10 cycles of IR and continuous R.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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:
a. 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
a) 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04939844
|Zealand University Hospital|
|Roskilde, Denmark, 4000|
|Oslo University Hospital|
|Helse Stavanger HF|
|St. Olav University Hospital|
|Principal Investigator:||Fredrik H Schjesvold, MD, PhD||Oslo University Hospital|
|Responsible Party:||Fredrik Hellem Schjesvold, Head of Oslo Myeloma Center., Oslo University Hospital|
|Other Study ID Numbers:||
|First Posted:||June 25, 2021 Key Record Dates|
|Last Update Posted:||March 1, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Physiological Effects of Drugs
Angiogenesis Modulating Agents