Trials Sponsors Conditions Drugs Pricing

Conditions

Multiple myeloma

Outcome Measures

Primary Outcomes (1)

Enhancement of ORR (yes/no), defined as “yes” for patients that show an increase in ORR at Visit 15 (start of cycle 4) as compared to Visit 2 (baseline), and “no” otherwise.

Secondary Outcomes (7)

Overall Response Rate (ORR, scores 1-7) defined as the highest class fulfilled by the patient at one time point: 1. PD, 2. SD or MR (SD, not fulfilling PD, MR, PR, VGPR or CR, or Minimal Response, ≥ 25% reduction in serum M-protein), 3.PR ≥ 50% reduction in serum M-protein, 4. VGPR ≥ 90% reduction in serum M-protein, 5. CR (Serum immunofixation not measurable), 6. Flow MRD negative, 7. Sustained MRD negative (compared to Visit 2)
Treatment-emergent adverse events/serious adverse events (TEAEs/SAEs) (including IARs)
Laboratory parameters
Vital signs
Weight
+2 more secondary outcomes

Interventions

SARCLISA 20mg/mL concentrate for solution for infusion.Type not reported

CellProtectType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
SARCLISA 20mg/mL concentrate for solution for infusion.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

SARCLISA 20mg/mL concentrate for solution for infusion.
Named ingredient: isatuximab
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Active multiple myeloma, as defined by the IMWG criteria
Evidence of measurable disease: Serum monoclonal (M)-protein ≥1.0 g/dL measured using serum protein immunoelectrophoresis a. and/or
Urine M-protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis a. and/or

Sponsors & Collaborators

Karolinska Institutet
Otherlead

Study Sites (1)

Karolinska University Hospital

Huddinge, 141 86, Sweden

Johan Lund+46 johan.l.lund@regionstockholm.se

Central Study Contacts

Eva Hellström Lindberg

0046852480000 eva.hellstrom-lindberg@ki.se

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

September 16, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-514527-42-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 05:12:30 UTC

Documents

ISA-HC-NK Study Protocol Clean

You may not qualify if:

Prior or concurrent exposure to NK cells and NK like T cells, or Approved or investigational treatments for MM
Received any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer
Diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma (asymptomatic multiple myeloma with absence of related organ or tissue impairment end organ damage)
Diagnosis of Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
Prior or current systemic therapy, or SCT for symptomatic multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids, if completed within 14 days prior to randomization
Concomitant plasma cell leukemia
Any major procedure within 14 days before the initiation of the study treatment: plasmapheresis, major surgery (kyphoplasty is not considered a major procedure), radiotherapy (except if palliative intent)
ECOG PS >2
Hemoglobin <8 g/dL
Platelets <70 × 109/L if <50% of bone marrow (BM) nucleated cells are plasma cells, and ≤30 × 109/L if ≥50% of BM nucleated cells are plasma cells. Platelet transfusion is not allowed within 3 days before the screening haematological test
Total bilirubin >1.5 × upper limit of normal (ULN), except for known Gilbert syndrome
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 × ULN
Hypersensitivity (or contraindication) to dexamethasone, sucrose histidine (as base and hydrochloride salt), boron, mannitol, and polysorbate 80 or any of the components of study therapy that are not amenable to premedication with steroids, pregelatinized starch, sodium stearyl fumarate, arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study therapy that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents
Second/third degree heart block within 6 months prior to randomization
Poorly controlled hypertension within 6 months prior to randomization
+9 more criteria

An open, randomised, controlled phase II trial of CellProtect in combination with Isatuximab antibody versus Isatuximab antibody alone as maintenance treatment in patients with Multiple Myeloma undergoing high dose treatment (ISA-HC-NK)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations