Rapid Infusion Isatuximab for Multiple Myeloma

Phase-Based Estimates
University of California San Francisco, San Francisco, CA
Multiple Myeloma+3 More
Rapid Infusion Isatuximab - Biological
All Sexes
Eligible conditions
Multiple Myeloma

Study Summary

This study is evaluating whether a faster infusion of isatuximab may be safe for patients with multiple myeloma.

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Eligible Conditions

  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Rapid Infusion Isatuximab will improve 1 primary outcome and 1 secondary outcome in patients with Multiple Myeloma. Measurement will happen over the course of 9-12 weeks depending on isatuximab dosing interval.

Week 12
Mean per-participant infusion duration
Up to 6 months
Number of participants with reported grade 2 or higher infusion-related reactions (IRR)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Treatment (isatuximab)

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. Rapid Infusion Isatuximab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (isatuximab)
Participants receive their first rapid infusion of isatuximab IV over 30 minutes. If a >=Grade 2 iRR occurs, then participants will revert to a SOC infusion time and be removed from the study. If a Grade 1 or no IRR occurs, then participants will receive another rapid infusion of 30 minutes. Participants will continue to receive RI and IRR assessment after each dose up to at least 6 doses or until a grade 2 or higher IRR occurs.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 months for reporting.

Closest Location

University of California San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Myeloma or one of the other 3 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically confirmed diagnosis of multiple myeloma (International Classification of Disease (ICD-10) code: C90.0)
Previous exposure to at least one proteasome inhibitors (PI) and lenalidomide (or candidacy for isatuximab as per updated Food and Drug Administration (FDA) package insert information in the future)
Planned or current isatuximab-containing therapy. Patients receiving isatuximab as part of a clinical trial are eligible for this study if allowed by the trial sponsor.
For ease of registration, patients will be allowed to enroll at any point after the decision is made to initiate isatuximab (with the understanding that their initial doses will be standard of care (SOC), including the first 2 doses for all patients). However, rapid infusion (RI) isatuximab will only be administered to participants who have not had infusion-related reactions (iRRs) during >= 2 consecutive prior doses of SOC isatuximab
Ability to understand a written informed consent form (ICF) document, and the willingness to sign the ICF document

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes multiple myeloma?

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Most multiple myeloma are idiopathic and do not seem to have a specific cause or cause. It is more common in older patients and in those with autoimmune diseases. More studies of multiple myeloma are needed to better understand and treat the disease.

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What is multiple myeloma?

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The following is an explanation of the myeloma concept. Please note:\n\nBacille Calmette, the microbiologist who first identified the "Mycoplasma pneumoniae" organism in 1849, gave it the name pneumococci, which would have made it the first bacterium described by modern science (1848), and a member of the phylum "Bacteriens", where members can grow in chains or as single cells. The word "bacterium" would have a "bad" connotation of small, rodlike, and not very infectious.

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What are common treatments for multiple myeloma?

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In patients suffering from relapsing/refractory multiple myeloma, conventional cytotoxic drugs are not the first or preferred treatment, since they only offer a modest improvement over treatment with oral agents that induce remissions. On the contrary, patients with very fast-developing, progressive, more-aggressive forms of multiple myeloma are usually given a combination of bortezomib with carfilzomib or bevacizumab and autotransplantation of the bone marrow.

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What are the signs of multiple myeloma?

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Signs of multiple myeloma include malaise, weight loss, decreased appetite and easy bruising and bleeding. Lymphadenopathy is one of the most common clinical manifestations of multiple myeloma.

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How many people get multiple myeloma a year in the United States?

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It is difficult to estimate the number of cases of [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) in the general population from a single national prevalence study. The national and regional prevalence estimates differ greatly, and estimates for single years must be interpreted with caution. It is difficult to determine whether trends in incidence are continuing for multiple myeloma or whether increases in incidence reflect increases in diagnosis, not in patient numbers. If incidence is rising, it is unlikely that many cases are newly diagnosed at a time when patients with myeloma have low survival rates, which may distort the estimates of incidence. If the incidence is not rising, detection of cases is likely to have risen in proportion to the actual number of new cases.

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Can multiple myeloma be cured?

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Survival in MM varies depending on the stage at presentation, but it is very likely that improvements in treatment are necessary to allow control of the disease.

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Does rapid infusion isatuximab improve quality of life for those with multiple myeloma?

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Given a favorable side effect profile, the data demonstrate for the first time that isatuximab in this way produces significant and lasting benefit on QoL among patients with multiple myeloma, and further supports the early application of the drug in this difficult-to-treat population.

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Have there been any new discoveries for treating multiple myeloma?

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The clinical data for new drug treatments of multiple myeloma are currently accumulating. Continued trials are needed to confirm the role of new drug therapies in MM treatment.

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What is the primary cause of multiple myeloma?

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Both myeloma (45% of cases) and Waldenström disease (10% of cases) are associated with primary malignancy. Although the etiology of BMF is unknown, its association to multiple myeloma implicate B-cell proliferation and/or cytokines as the pathogenic processes for BMF and multiple myeloma, respectively.

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What are the common side effects of rapid infusion isatuximab?

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ISA is well tolerated by patients receiving treatment for relapsed or refractory myeloma. The most common side effects are infusion reactions, febrile neutropenia, and infection, and neutropenia was the most troublesome. Because of the potential toxicity of an immune deficiency state, a slow infusion rate (for 10–12 hours or less) was recommended when starting ISA.

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What is the latest research for multiple myeloma?

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The number of treatment options for patients with multiple myeloma has increased significantly during the last decade, and new treatment options are being launched at an increasing pace. The number of patients with refractory multiple myeloma has remained relatively static, so some of the new treatments may have less-than-expected utility in the clinical setting.

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Does multiple myeloma run in families?

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Results from a recent clinical trial suggests that multiple myeloma is genetically and biologically heterogeneous. Some cancers may be the result of simple genomic changes (single nucleotide polymorphisms, SNPs), whereas others may reflect complex genetic interactions among numerous loci.

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