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Can I no longer use new drugs after starting dialysis?
As you continue treatment for myeloma, your kidney function may decline, leading to the start of dialysis. When people hear that “a new immunotherapy drug has become available” during such a time, many often think, “That is not something that applies to me while I am on dialysis.”
Myeloma is a disease that easily puts a strain on the kidneys. However, major clinical trials for new drugs have almost never included patients with severe kidney impairment or those on dialysis.
Because it has not been verified in large-scale trials, it was unknown whether these drugs would be effective or safe for patients on dialysis. So, what actually happened to those who used them?
A research group reviewed and reported on the progress of four patients who were treated with a drug called elranatamab while undergoing dialysis, based on their medical records. From here, we will trace the details, starting with the relationship between myeloma and dialysis.
Myeloma, the kidneys, and becoming dialysis-dependent
Declining kidney function due to myeloma
Myeloma is a disease in which plasma cells (cells that produce antibodies to protect the body) in the bone marrow become cancerous and multiply. Abnormal proteins produced by myeloma cells can put a strain on the kidneys.
According to the paper, approximately 20-40% of patients experience a decline in kidney function during the course of myeloma. Some of these cases progress to kidney failure requiring dialysis.
The paper states that when kidney damage progresses, survival time tends to shorten, and available treatment options become limited. Patients requiring dialysis have been in a position where it is difficult to participate in trials testing new drugs.
Treatment after three classes of drugs have stopped working
There are three main classes of drugs for the treatment of myeloma:
Proteasome inhibitors: Drugs that interfere with the mechanism that processes proteins within myeloma cells
Immunomodulatory drugs: Drugs that regulate immune function while suppressing the growth of myeloma
Anti-CD38 antibodies: Antibody drugs that bind to a marker (CD38) on the surface of myeloma cells
The paper states that the prognosis is particularly severe for patients with relapsed or refractory disease who no longer respond to any of these three classes.
Treatments targeting BCMA (B-cell maturation antigen) have significantly improved outcomes for such patients. BCMA is a marker on the surface of plasma cells. These include antibody-drug conjugates, CAR-T cell therapy, and bispecific antibodies.
What kind of drug is elranatamab?
Bringing myeloma cells and T cells together as if they were holding hands
Elranatamab is a type of drug called a bispecific antibody. While ordinary antibodies bind to a single target, this drug is designed to bind to two targets simultaneously.
The first target is BCMA on the surface of myeloma cells. The second is CD3 on the surface of T cells, which play a central role in immunity.
In other words, it is a drug that brings myeloma cells and T cells together as if they were holding hands. T cells are immune cells in the body that attack foreign substances and cancer cells. The brought-together T cells then attack the myeloma cells. The paper describes the drug as one that redirects the T cells’ cell-damaging function toward myeloma cells.
Results in large trials and the positioning for those on dialysis
In one international collaborative Phase 2 trial, the proportion of patients with relapsed/refractory multiple myeloma who had undergone multiple lines of treatment who showed a response (response rate) was approximately 61%. Side effects were reported to be within a manageable range.
However, patients with severe renal impairment or those requiring dialysis were almost entirely excluded from these large trials. Data on patients undergoing dialysis was extremely limited.
A usage method of gradually increasing from a small dose
For this drug, a usage method of gradually increasing the dose from a small amount (step-up) rather than using a fixed amount from the beginning is established. The idea is to acclimate the patient while observing their reaction. After the step-up dosing, administration becomes once a week, and for those whose effects have stabilized, it is switched to once every two weeks.
This usage method is important when reading the progress of the four patients.
A study reviewing four patients on dialysis
This study is a report summarizing four patients with relapsed/refractory multiple myeloma who were treated while undergoing dialysis, reviewed from medical records. All four consecutive patients who received treatment during the period are included. There was no comparison with a group not using the drug, nor was the treatment decided by lottery.
The drug was administered according to the established standard usage. Efficacy was judged by international criteria, and side effects were evaluated by grades (the larger the number, the more severe). The paper states that written consent was obtained from everyone.
Patients included
The subjects were patients whose chronic kidney disease had progressed to stage 4-5 and who were receiving maintenance dialysis (regular, ongoing dialysis). Three main classes of drugs had all become ineffective, and they had never received treatment targeting BCMA.
Numbers indicating kidney function
Kidney function is expressed by eGFR (a measure of kidney function calculated from blood tests). The lower the value, the weaker the kidney function. The values for the four patients before starting treatment were in the range of 5-20 mL/min. All of them were undergoing dialysis.
What kind of people were the four patients?
The ages of the four patients ranged from 61 to 80, with a median of 67. Three were male. The types of myeloma were light chain only in two patients, IgGλ type in one, and IgAλ type in one. This refers to the difference in the types of abnormal antibodies produced by myeloma cells.
Regarding the disease stage, according to the ISS (a classification that expresses the progression of myeloma in stages 1-3), three patients were in stage 3 and one was in stage 1. The higher the number, the more advanced the state.
Past treatments ranged from 4 to 7 lines (median was 6), and one patient had undergone autologous transplantation (transplantation using their own hematopoietic stem cells) twice.
The progress of each of the 4 patients
Here, we will look at the progress of the 4 patients described in detail in the paper, one by one.
Patient 1: A person who has maintained a complete response after overcoming severe pneumonia
A 62-year-old male. He had IgGλ-type myeloma, and his stage at diagnosis was stage 3. He had received 6 lines of treatment in the past and had also undergone 2 autologous transplants. All major drugs from 3 classes had become ineffective.
At the time elranatamab was started, his kidney function indicator (eGFR) was 9 mL/min. He had end-stage renal failure and was receiving maintenance dialysis. Treatment began with the standard step-up dosing. Neither cytokine release syndrome (CRS: an inflammatory reaction such as fever caused by a strong immune response}) nor neurotoxicity (ICANS: neurological symptoms such as consciousness or speech issues that can occur with treatments using immune cells) occurred.
During the course of treatment, he developed severe pneumonia. He was hospitalized and required treatment in the intensive care unit (ICU). Doses for the 8th and 9th cycles were skipped, and treatment was interrupted for about 2 months. The pneumonia subsided with antibiotic treatment.
Because the interruption was shorter than 12 weeks, treatment was resumed without repeating the step-up dosing. “Without repeating” means that the procedure of increasing the dose from the initial small amount was not performed again. The paper states that this was in accordance with the recommendations in the package insert.
As of the data cutoff, treatment had reached a total of 14 cycles. A complete response continues, and there is no disease progression. Even after the pneumonia, immunoglobulin replacement and prophylactic medication for infection were continued.
Patient 2: A person who had only mild side effects and deepened to a complete response
A 73-year-old female. She had light-chain-only myeloma (λ-type), and her stage at diagnosis was stage 3. Chromosomal testing evaluated her as standard risk. She had received 7 lines of treatment in the past, and 3 classes of major drugs had become ineffective.
Her kidney function indicator at the start of treatment was 20 mL/min, and she was receiving maintenance dialysis. Treatment was conducted using the standard method.
During treatment, grade 1 CRS occurred, but it recovered naturally without any special intervention. No neurological symptoms or severe infections occurred.
After 6 cycles of treatment, she reached a VGPR (very good partial response), which is close to a complete response. Because the efficacy and safety were good, treatment was continued, and it deepened further during the course to a complete response. As of the data cutoff, she had received 12 cycles, and the complete response continues.
Patient 3: A person who continues to have a partial response
A 61-year-old male. He had IgAλ-type myeloma, and his stage at diagnosis was stage 1. Chromosomal testing showed standard risk. He had received 7 lines of treatment in the past, and 3 classes of major drugs had become ineffective. He had not received an autologous transplant.
He developed end-stage renal failure due to myeloma and was receiving chronic dialysis. His kidney function indicator at the start of treatment was 8 mL/min.
He received treatment using the standard method, and neither CRS, ICANS, nor severe infections occurred. However, grade 4 lymphopenia occurred. This is a state where lymphocytes in the blood are significantly reduced, but he recovered afterward.
As of the data cutoff, he had finished 9 cycles of treatment and treatment is ongoing. The best effect was a partial response (PR), and that state continues.
Patient 4: An 80-year-old person who had the lowest kidney values
An 80-year-old male. He had light-chain-only myeloma (λ-type), and his stage at diagnosis was stage 3. Chromosomal testing showed standard risk. He had received 4 lines of treatment in the past, and 3 classes of major drugs had become ineffective. He had not received an autologous transplant.
The patient was on maintenance dialysis due to severe renal impairment, and their baseline kidney function before starting treatment was 5 mL/min, the lowest value among the four.
The treatment was well tolerated, and no CRS, ICANS, or severe infections occurred. As of the data cutoff, the patient had received 6 cycles of treatment and VGPR is ongoing.
Overall Efficacy and Side Effects
Efficacy: All 4 patients showed a response
As of the data cutoff, all 4 patients were evaluable for efficacy. The breakdown is as follows:
Complete Response (CR: a state where myeloma is no longer detectable by tests) was seen in 2 out of 4 patients
VGPR (a deep partial response close to complete response) was seen in 1 out of 4 patients
Partial Response (PR) was seen in 1 out of 4 patients
Complete response means it is no longer detectable by tests, but it does not necessarily mean a cure. Both patients are continuing treatment.
All 4 patients showed a response, resulting in an overall response rate of 100%. A deep response of VGPR or better was observed in 3 out of the 4 patients. All are continuing treatment, with a duration ranging from 6 to 14 months since the start of therapy.
The paper compares these results to the aforementioned large-scale trial (overall response rate of approximately 61%, with 31.7% achieving complete response or better) and describes them as favorable outcomes. However, the paper itself cites the small sample size as a limitation. Because the subjects and conditions differ between the 4 patients and the participants in the large-scale trial, it is not possible to determine superiority by simply comparing the numbers.
Hearing ‘100%’ sounds like a very good result. However, with a sample size of only 4, a change in the outcome of just one person shifts the percentage by 25 points. The observation period is 6 to 14 months, and all patients are still undergoing treatment. Since this is a retrospective study of medical records, cases with successful outcomes may be more likely to be reported. These figures should be taken as a clue that ‘there is a possibility of efficacy in patients on dialysis’.
Side Effect 1: Cytokine Release Syndrome (CRS)
CRS is a representative side effect that can occur with this type of drug. It causes symptoms such as fever due to the release of substances (cytokines) produced when immune cells are activated and cause inflammation.
Out of the 4 patients, CRS occurred in 1 person, and it was a mild Grade 1 case. It resolved spontaneously. No cases of Grade 2 or higher CRS were reported.
Side Effect 2: Neurotoxicity (ICANS)
ICANS is a neurological symptom specific to treatments that utilize the power of the immune system. Among the 4 patients, it did not occur in anyone. The paper states that this result is consistent with large-scale trials and past reports on patients undergoing dialysis, and it suggests that neurotoxicity does not appear to increase even in the presence of renal failure.
Side Effect 3: Infections and Effects on Blood
Infections are considered the side effect that requires the most caution with this drug. According to the paper, bispecific antibodies targeting BCMA are prone to increased infections for two reasons. One is a significant decrease in antibodies in the blood (hypogammaglobulinemia). The other is that T-cell activity continues to be redirected toward myeloma cells for a long period. In clinical studies, Grade 3 or higher infections have been reported in approximately 20-30% of patients who received this type of treatment.
Among the 4 patients, the only severe infection was pneumonia in the first patient. Treatment was temporarily interrupted, but the patient recovered and resumed therapy. There were no opportunistic infections (infections that rarely occur under normal conditions but happen when immunity is low), treatment-related deaths, or permanent discontinuation of treatment due to infection.
A rate of one in four does not indicate that infections were rare. It is reasonable to accept this as confirmation that infections can occur. Also, because everyone received the same infection prevention, it is impossible to separate whether the mild nature of the infections was due to the prevention or the nature of the drug itself.
The paper states that the impact on the blood was limited. The only Grade 4 case was the lymphopenia in the third patient mentioned earlier.
No unexpected side effects or dialysis-related complications were reported. No one discontinued treatment due to side effects, and all four patients were alive and continuing treatment.
The paper points out that dialysis itself is a factor that increases the risk of infection. Therefore, it states that careful monitoring and proactive infection control measures are essential.
How infections were prepared for
All four patients received the following infection control measures after dialysis.
Sulfamethoxazole/trimethoprim: A drug to prevent Pneumocystis pneumonia, which is common when immunity is low
Valacyclovir: An antiviral drug to prevent viral infections such as herpes
Levofloxacin: An antibacterial drug to prevent bacterial infections
Immunoglobulin replacement: A treatment to supplement reduced antibodies via intravenous drip
The paper discusses the possibility that these preventive drugs and immunoglobulin replacement may have mitigated the severity of infection-related illnesses. Even so, one patient developed severe pneumonia, meaning that infection could not be completely prevented despite these preparations.
In other words, the results of this study are based not only on the drug itself but also on the combination with infection preparedness. This point will be touched upon later in “How much can be concluded?”
Are the dosage and efficacy of the drug the same even during dialysis?
What concerns those on dialysis is whether the drug will accumulate in the body or be removed by dialysis.
According to the paper, previous analyses have shown that the body’s drug levels do not change much in patients with mild to moderate renal impairment. Data on end-stage renal failure is limited, but no side effects due to drug accumulation were seen in these four patients or in past reports. The paper states that standard usage is reasonable for those on dialysis.
However, the pharmacokinetics of the drug in patients on dialysis have not been officially investigated. Therefore, the method of administration after dialysis is positioned as a practical approach that has been used in many previous reports.
Comparing with previous reports
The paper also summarizes in a table three previously reported cases of patients with relapsed/refractory myeloma on dialysis who used elranatamab. All were women, aged 79, 72, and 68.
All three patients had deep responses. One reached a complete response one month after starting treatment, which continued at the four-month mark. One reached a deep complete response with minimal residual disease (MRD) negativity, which continued at the 11-month mark. Another was in complete response and MRD negative at the four-month mark.
CRS was Grade 1 in all three patients, but all three were treated with an anti-inflammatory drug (tocilizumab). One case was prolonged, and another recurred. In the current four patients, CRS occurred in only one and resolved spontaneously. Neurotoxicity did not occur in any of the three.
There were also infections and complications. Pneumonia caused by COVID-19, cholangitis, and exfoliative dermatitis (an inflammation where the skin peels off over a wide area) have been reported. The contents of this table are based on previous studies cited by the paper.
Including these four patients, there are now seven reports of elranatamab being used during dialysis. The paper states that the efficacy was consistently high across all seven patients. It also notes that CRS was mainly mild, there was no neurotoxicity, and infections were manageable with appropriate prophylaxis. However, for three of the seven patients, the information was drawn by the paper from previous studies. Among the four patients in this study, one required treatment in the intensive care unit for pneumonia.
Comparing with other BCMA-targeted therapies
The paper states that favorable outcomes have also been reported for patients on dialysis using teclistamab, a bispecific antibody that also targets BCMA. While there was no increase in high-grade CRS or ICANS, infections were frequent.
For the CAR-T cell therapy idecabtagene vicleucel, there is a retrospective analysis that examined patients with renal impairment (including end-stage renal failure). The paper states that the efficacy was comparable, and transient cytopenia was common.
Combining these, the paper summarizes as follows: BCMA-targeted immunotherapy should not be excluded from the outset solely because of advanced renal impairment. However, adequate support for issues such as infection is a prerequisite.
What can be concluded
I will organize the results so far by separating what can be said from what cannot.
What can be said is that all four patients with relapsed/refractory myeloma undergoing dialysis showed a response. A serious infection occurred in one patient, and no neurotoxicity occurred. The trend was similar for the seven patients when combined with the three from the past.
On the other hand, there are things that cannot be said.
First, the number of patients is small at four. This is a study that looked back at medical records, and there is no comparison group. Therefore, it cannot be said that these results apply directly to all myeloma patients on dialysis. It is possible that cases with successful outcomes are more likely to be reported.
Second, the observation period is short. It has been 6 to 14 months since the start of treatment, and all patients are still undergoing treatment. The efficacy and safety of long-term continuation are not yet known. The paper also cites the relatively short follow-up for some patients as a limitation.
Furthermore, regarding infections, as mentioned earlier, the effects of prophylaxis and the nature of the drug itself cannot be separated. Also, the pharmacokinetics of the drug in patients on dialysis have not been formally investigated.
Finally, a note on how to read the numbers. The first patient is recorded as having 14 cycles over 14 months, but there was an interruption of about 2 months. For this reason, the method of counting cycles cannot be read from the paper.
For these reasons, the paper states that it is necessary to verify this in larger prospective studies. Whether this treatment is suitable for your own medical condition cannot be determined from this paper. The appropriateness of treatment should be decided in consultation with your attending physician.
Summary
In myeloma, about 20-40% of patients have reduced kidney function, and some of them require dialysis. Patients on dialysis have rarely been included in large trials of new drugs.
Elranatamab is a bispecific antibody that connects BCMA on myeloma cells to CD3 on T cells, causing the T cells to attack the myeloma cells.
Among four patients with relapsed/refractory myeloma undergoing dialysis, all showed a response, with 2 achieving complete response, 1 achieving VGPR, and 1 achieving partial response.
CRS was grade 1 in only one patient, and no neurotoxicity occurred. A serious infection occurred in one patient as pneumonia, and treatment was able to be resumed.
All patients received prophylactic anti-infectives and immunoglobulin replacement. Dialysis itself also increases the risk of infection.
Due to the small sample size of four patients and the observation period of 6 to 14 months, no definitive conclusions can be drawn. Large prospective studies are needed.
Returning to the initial question: it has been suggested that we do not necessarily have to assume that new immunotherapies cannot be used from the start, even if a patient is on dialysis. However, the verification stage is just beginning, and more time and validation are still required.
Thoughts after reading this paper
This study reported that all four myeloma patients on dialysis showed a response to treatment, with one patient experiencing a serious infection. I feel that we should avoid narrowing the available treatment options from the outset solely because a patient is on dialysis. On the other hand, I believe we must accept that this is still a preliminary finding, as definitive conclusions cannot be drawn from such a small group. The paper also states that, provided preparations for infection are in place, patients should not be excluded from treatment solely due to advanced kidney impairment. I want to value both having hope and not having excessive expectations.
Scope of this article (General Information)
This article provides an easy-to-understand summary of general information from a case series reporting on elranatamab treatment for relapsed/refractory multiple myeloma in patients on dialysis. It does not indicate individual diagnoses or treatment policies. If you have any concerning symptoms, we recommend consulting a medical institution.
The treatment introduced here is not established for use in patients on dialysis. Whether or not to undergo treatment is determined by the attending physician based on the patient’s medical condition and kidney status.
Symptoms that warrant consideration of a medical consultation
If you are undergoing myeloma treatment or dialysis and notice any of the following changes, we recommend consulting your doctor without waiting for your next scheduled visit.
If you develop a fever around 38°C, chills, or shivering.
If you have persistent or worsening cough or shortness of breath.
If you experience persistent severe fatigue, loss of appetite, or a feeling of being unfocused.
If you feel that your physical condition after dialysis is different from usual.
If bone pain persists or becomes stronger.
If you develop numbness in your hands or feet, or difficulty applying strength.
If you are receiving treatment that utilizes the power of the immune system, please contact your medical institution without self-judging if you experience unusual symptoms such as fever, shortness of breath, dizziness, or confusion.
References
Batgi H, Dilan Köseoğlu F, Çetin D, Başcı S, Namdaroğlu S, Akad Soyer N. Elranatamab in relapsed/refractory multiple myeloma patients on hemodialysis: A real-world case series. Clin Hematol Int. 2026;8(3):60-66. doi:10.46989/001c.171328
Disclaimer
This article is intended to provide general health information and is not a substitute for medical practice. For individual symptoms and treatments, please be sure to visit a medical institution and consult with a doctor. The content of this article is based on information available at the time of writing.
