Assessment of chemotherapy-related adverse drug reactions among multiple myeloma patients at Kenyatta national hospital

Abstract

Background

Despite treatment modalities for multiple myeloma can cause adverse drug reactions (ADRs), data are scarce about the types, severity and preventability of chemotherapy-related ADRs in Kenya. This study aimed to assess the chemotherapy-related ADRs among multiple myeloma patients at Kenyatta National Hospital (KNH).

Methods

A one-arm retrospective cohort study was carried out among all eligible adult patients with a documented diagnosis of multiple myeloma between 1^st January 2017 to 31^st December 2023. A data abstraction tool was used to assess sociodemographics, clinical characteristics and chemotherapy-related ADRs. The Schumock and Thornton scale and the modified Hartwig and Siegel severity scale were employed to evaluate the preventability and severity of ADRs, respectively. Data analysis was performed using the Statistical Package for Social Sciences (SPSS) version 29.0 software. The results were presented using mean, frequency and percentage. Binary logistic regression was employed to assess factors influencing ADRs. A p-value of less than 0.05 was considered statistically significant.

Results

The prevalence of ADRs in this study was 81.5% with a total of 230 ADRs identified. The primary ADRs identified were peripheral neuropathy (21.7%), nausea and vomiting (14.8%), neutropenia (12.2%) and anemia (11.3%). The majority of the ADRs (51.7%) were moderate in severity, and 29.8% were of mild severity. Preventability assessments of the ADRs showed that most of them (68.2%) were definitely preventable and 13.2% were probably preventable. VRD (Bortezomib/Lenalidomide/Dexamethasone) and VCD (Bortezomib/Cyclophosphamide/Dexamethasone) treatment regimens were responsible for most of the ADRs. VRD (AOR = 11.1, 95% CI = 3.7–32.8, p < 0.001) and VCD treatment regimens (AOR = 4.8, 95% CI = 1.1–20.0, p = 0.033) were the significant factors affecting the occurrence of ADRs.

Conclusion

Overall, the incidence of chemotherapy-related ADRs in multiple myeloma patients at KNH was notably high (81.5%). Despite the moderate severity of the ADRs, their preventable nature highlights the potential for improved patient outcomes through careful regimen selection and monitoring.

Keywords

Adverse drug reactions severity preventability multiple myeloma Kenya

Introduction

Multiple Myeloma (MM) is a haematological cancer affecting plasma cells, marked by the abnormal production of a monoclonal protein (M-protein). It is identified by bone lesions, anemia, and renal insufficiency. Although considered a rare cancer on a global scale, MM is the second most prevalent hematologic malignancy worldwide, surpassed only by non-Hodgkin lymphoma. It registers an annual global incidence of 103,826 new cases and results in 72,453 fatalities.¹ The American Cancer Society estimates 35,730 new cases of MM in the United States in 2023 with an estimated 12,590 deaths from the disease.²

In sub-Saharan Africa, there is limited data, but studies suggest that there is a lower incidence and prevalence of MM in this region compared to other parts of the world.³ This may be due to various factors such as underdiagnosis and limited access to healthcare resources. In the Eastern Africa region, 2500 newly diagnosed cases of MM were reported in the year 2018.⁴ This suggests a relatively lower prevalence compared to other more common cancers in Kenya, such as breast, cervical, and prostate cancers.

Over the years, the field of oncology has continued to advance in inventing new ways to manage cancer including chemotherapy. Chemotherapy plays a significant role in the treatment of MM, aiming to suppress cancer cell growth, reduce tumour burden, and improve patient outcomes. As the number of treatments advances, so does the risk. These risks are clinically known as adverse drug reactions (ADRs). ADRs are described as unpleasant or harmful events resulting from the use of a medicinal.⁵ Chemotherapy has been associated with various ADRs, which can significantly impact patients’ well-being, treatment adherence, and overall quality of life.⁶ Therefore, ADRs are one of the important factors used to assess the effectiveness of the treatment.

Chemotherapy-related ADRs in MM patients can manifest in various organ systems and can include haematological complications (such as neutropenia, anaemia, and thrombocytopenia), gastrointestinal issues (such as nausea, vomiting and diarrhea), peripheral neuropathy, fatigue, dermatological reactions, hepatotoxicity, and renal toxicity.⁷ These ADRs significantly impact patients’ overall well-being and functional status, contributing to decreased quality of life. As a result, mitigation such as dose reductions, treatment delays, or discontinuation is implemented, leading to suboptimal treatment efficacy and potential compromises in patient outcomes.⁶ Therefore effective assessment and mitigation of these ADRs are essential to optimize treatment outcomes and enhance patients’ quality of life during their cancer journey.

The assessment of chemotherapy-related ADRs in MM patients is crucial to identify the incidence, severity, and management strategies for these complications. Understanding the specific ADRs associated with different chemotherapy agents or regimens can help guide treatment decisions, optimize supportive care measures, and improve patient safety and well-being. Previous studies have investigated ADRs in MM patients,^8–15 however, comprehensive research is needed to provide a deeper insight into the distinct profiles of ADRs, identify risk factors and determine effective interventions within this patient demographic. Hence, this study aimed to assess the prevalence, types, severity and preventability of chemotherapy-related adverse drug reactions in multiple myeloma patients at Kenyatta National Hospital.

Methods

Study design, setting and period

A one-arm retrospective cohort study design was employed to assess chemotherapy-related ADRs among MM patients who received treatment at KNH between 1^st January 2017 to 31^st December 2023. The research was conducted over three months, from 1^st December 2023 to 29^th February 2024, within the Oncology Department at Kenyatta National Hospital. KNH is a level 6 hospital situated in the area known as Upper Hill, about 5 kilometers southwest of the city center. It has a substantial bed capacity, with over 1800 beds available for patient care. It functions as a national referral center, offering dedicated facilities for both teaching and research.

Study population

The study population consisted of the medical records of eligible MM patients who have been treated at the Oncology Department of KNH between 1^st January 2017 to 31^st December 2023.

Eligibility criteria

Inclusion criteria

Adult multiple myeloma patients (≥18 years of age) treated at the Oncology Department of KNH between 1^st January 2017 to 31^st December 2023, had complete records of their diagnosis and treatment regimens and underwent at least one cycle of chemotherapy were included in the study.

Exclusion criteria

Patients with multiple myeloma who had insufficient medical records regarding their diagnosis and treatment regimen, as well as those who did not receive chemotherapy, were excluded from the study.

Sample size and sampling techniques

The sample size was a census. It included all MM patients who met the inclusion criteria and were treated at KNH between 1^st January 2017 to 31^st December 2023. All eligible MM patients treated at the Oncology Department of KNH from 1^st January 2017 to 31^st December 2023 were investigated. A total enumerative sampling technique was used due to the small number of patients with MM at Kenyatta National Hospital.

Research instruments

A data abstraction tool was employed to gather information from patients’ medical records. The tool included crucial information like as socio-demographic factors of the patients, histological grade and characteristics of the malignancy, treatment regimen used and chemotherapy-related ADRs. The Schumock and Thornton Scale was employed to evaluate the preventability of ADRs, classifying them into those that are preventable (either probably or definitely preventable) and those that are not preventable.¹⁶ The modified Hartwig and Siegel Severity Scale was utilized to categorize the severity of ADRs into mild (levels 1 and 2), moderate (levels 3 and 4), and severe (levels 5, 6, and 7) categories.¹⁷

Pretesting

The reliability and validity of the data collection tool were enhanced by conducting a preliminary test on 5% of the entire sample size. Modifications were made before the primary research in case of any error.

Data collection techniques

To access the medical records of the patients, the principal investigator requested authorization from the Health Information Department at KNH. Relevant patient charts were reviewed using structured data abstraction tables. Patients’ files were assessed for sociodemographic characteristics, histologic subtype, clinical characteristics, treatment modality, comorbidities, and chemotherapy-related ADRs. The preventability and severity of ADRs were assessed after reviewing the medical records of the patients.

Data analysis

The data collected was analysed by using SPSS version 29.0.01 software. Mean was used to report the age of the participants. Other socio-demographic variables such as marital status and education level were reported in the form of percentages and frequency. Univariable and multivariable binary logistic regression were used to assess factors affecting ADRs. The p-value <0.05 was considered statistically significant.

Results

Socio-demographic characteristics of multiple myeloma patients

A total of 478 multiple myeloma patients were treated in the facility from 1^st January 2017 to 31^st December 2023. However, the medical records of only 307 patients were traced. Out of these traced medical records, 151 multiple myeloma patients met the eligibility criteria and were included in the study (Figure 1).

In this study, the mean age of the multiple myeloma patients was 58.5 ± 10.9 years with the majority of them being below 60 years (N = 81,53.6%). Of the total study patients, 51% (N = 77) were males while 49% (N = 74) were females. Moreover, most of the patients (N = 76, 50.3%) had a tertiary level of education whereas, 26.5% (N = 40) had a secondary level, 18.5% (N = 28) had a primary level and 4.6% (N = 7) were unable to read or write (Table 1).

Table 1.

Socio-demographic characteristics of patients (n = 151).

Variable	Frequency	Percent (%)
Age (years)
< 60	81	53.6
≥ 60	70	46.4
Gender
Male	77	51
Female	74	49
Marital status
Single	2	1.3
Widowed	8	5.3
Married	141	93.4
Level of education
Illiterate	7	4.6
Primary	28	18.5
Secondary	40	26.5
Tertiary	76	50.3
Employment status
Retired	15	9.9
Employed	41	27.2
Private employee	43	28.5
Unemployed	52	34.4

Clinical characteristics and treatment regimen

The predominant clinical presentation at diagnosis was osteolytic bone lesion (N = 111, 33.1%), whereas 31.9% (N = 107) presented with anemia, 21.8% (N = 73) had renal insufficiency and 13.1% (N = 44) had hypercalcemia. The majority of the patients (N = 95, 62.9%) had comorbidities while 37.1% (N = 56) did not have co-existing comorbidities (Table 2).

Table 2.

Clinical characteristics of study participants (n = 151).

Variable	Frequency	Percent (%)
Clinical presentation at diagnosis
Osteolytic bone lesion	111	33.1
Anemia	107	31.9
Renal insufficiency	73	21.8
Hypercalcemia	44	13.1
Comorbidity
Present	95	62.9
Absent	56	37.1
Number of comorbidities
None	56	37.1
1	63	41.7
2	22	14.6
≥3	10	6.6

In this study, the treatment modality of all the patients was chemotherapy. The initial chemotherapy regimen administered to the majority of the patients (55.6%) was VRD (Bortezomib/ Lenalidomide/ Dexamethasone) while 30.5% of patients were treated with VCD (Bortezomib/ Cyclophosphamide/ Dexamethasone) regimen.

The lowest proportion of patients (13.9%) were treated with Lenalidomide/Dexamethasone(RD), Melphalan/Prednisolone(MP), Bortezomib/Dexamethasone(VD), Cyclophosphamide/Dexamethasone, Melphalan/Cyclophosphamide/Prednisolone (MCP) regimens.

Adverse drug reactions among multiple myeloma patients

The prevalence of chemotherapy-related ADRs in this study was 81.5% with a total of 230 ADRs reported. The major ADRs reported were peripheral neuropathy (21.7%), nausea and vomiting (14.8%), neutropenia (12.2%) and anemia (11.3%) (Table 3).

Table 3.

Adverse drug reactions among study participants (n = 151).

Variable	Frequency	Percent (%)
Adverse drug reactions
Present	123	81.5
Absent	28	18.5
Types of adverse drug reactions
Peripheral neuropathy	50	21.7
Nausea and vomiting	34	14.8
Neutropenia	28	12.2
Anemia	26	11.3
Fatigue	20	8.7
Gastritis	17	7.4
Diarrhea	16	7.0
Thrombocytopenia	13	5.7
Constipation	11	4.8
Renal insufficiency	9	3.9
Fever	4	1.7
Deep vein thrombosis	2	0.9

The major ADRs were experienced by patients who received the VRD treatment regimen. Peripheral neuropathy, neutropenia, nausea/vomiting and anemia were the most common ADRs experienced among VRD-treated patients. Peripheral neuropathy and nausea/vomiting were the most common categories of ADRs among other treatment regimens treated patients, (Table 4).

Table 4.

Types of adverse drug reactions observed with the respective treatment regimen among study participants (n = 230).

	Types of treatment regimen
Type of adverse drug reaction	Others	VCD (Bortezomib/ Cyclophosphamide/ Dexamethasone)	VRD (Bortezomib/ Lenalidomide/ Dexamethasone)
Anemia	5 (7.8)	5 (14.7)	16(12.1)
Constipation	2(3.1)	2(5.9)	7(5.3)
Deep vein thrombosis	0(0)	0(0)	2(1.5)
Diarrhea	7(10.9)	1(2.9)	8(6.1)
Fatigue	5(7.8)	2(5.9)	13(9.8)
Fever	1(1.6)	1(2.9)	2(1.5)
Gastritis	5(7.8)	4(11.8)	8(6.1)
Nausea/vomiting	12(18.8)	4(11.8)	18(13.6)
Neutropenia	6(9.4)	5(14.7)	17(12.9)
Peripheral neuropathy	17(26.6)	5(14.7)	28(21.2)
Renal insufficiency	1(1.6)	3(8.8)	5(3.8)
Thrombocytopenia	3(4.6)	2(5.9)	8(6.1)

Other: Lenalidomide/Dexamethasone (RD), Melphalan/Prednisolone (MP), Bortezomib/Dexamethasone (VD), Cyclophosphamide/Dexamethasone (CD), Melphalan/Cyclophosphamide/Prednisolone (MCP).

Of the total 230 ADRs reported, assessment on severity showed that the majority of them (N = 78, 51.7%) were moderate and 29.8% (N = 45) were mild reactions. Preventability assessments of the ADRs showed that most of them (N = 103, 68.2%) were definitely preventable and 13.2% (N = 20) of ADRs were probably preventable (Figure 2).

Factors associated with adverse drug reactions among multiple myeloma patients

Univariable and multivariable binary logistic regression model was employed to determine the association between independent variables and ADRs. The independent variables included age, gender, presence of comorbidity and treatment regimen used. There was a statistically significant association in the type of regimen administered in both univariable and multivariable analyses. Patients who received VRD treatment regimens were 11.1 times (AOR = 11.1, 95% CI = 3.7–32.8, p < 0.001) more likely to develop ADRs as compared to those who received other treatment regimens. Additionally, those who received VCD treatment regimens were 4.8 times (AOR = 4.8, 95% CI = 1.1–20.0, p = 0.033) more likely to develop ADRs as compared to those who received other treatment regimens (Table 5).

Table 5.

Factors associated with adverse drug reactions among the study participants.

Variable	Univariable analysis		Multivariable analysis
	COR(95%CI)	P-value	AOR(95%CI)	P-value
Age
< 60 years	1	1	1	1
≥ 60 years	1.2(0.5–2.7)	0.681	1.8(0.7–5.2)	0.246
Gender
Female	1	1	1	1
Male	0.9(0.4–2.0)	0.762	1.2(0.5–3.1)	0.681
Comorbidity
Absence	1	1	1	1
Presence	1.6(0.7–3.7)	0.259	1.2(0.5–3.4)	0.681
Treatment regimen
Others	1	1	1	1
VRD	9.1(3.3–25.3)	<0.001*	11.1(3.7–32.8)	<0.001*
VCD	4.2(1.1–16.4)	0.037*	4.8(1.1–20.0)	0.033*

*Statistically significant with p-value <0.05, AOR: Adjusted Odd's Ratio, COR: Crude Odd's Ratio, CI: Confidence Interval.

Others: Lenalidomide/Dexamethasone (RD), Melphalan/Prednisolone (MP), Bortezomib/Dexamethasone (VD), Cyclophosphamide/Dexamethasone (CD), Melphalan/Cyclophosphamide/Prednisolone (MCP).

VRD: (Bortezomib/ Lenalidomide/ Dexamethasone), VCD: (Bortezomib/ Cyclophosphamide/ Dexamethasone).

Discussion

In the demographic analysis of this study, a notable proportion of males (51%) were diagnosed with MM compared to females (49%). The results align with the existing literature indicating that men are at a higher risk of developing the disease compared to women.^18,19 Several factors contribute to this gender disparity. Firstly, genetic predisposition plays a role, with men being more likely to develop MM as a result of hyperdiploidy. Additionally, there are differences in tumor genetics between men and women with MM, further influencing the higher incidence rates.²⁰ Lifestyle factors such as smoking have been associated with an increased risk of multiple myeloma in both men and women, with a stronger association observed in men.²¹ Moreover, dietary factors like acrylamide intake may increase the risk of multiple myeloma in men.²² Furthermore, hormonal influences have been considered in understanding the gender differences in MM. Sex hormones could potentially influence the incidence rates of multiple myeloma, contributing to the higher rates seen in men compared to women.²³

MM is clinically characterized clinically by the presence of hypercalcemia, renal insufficiency, anaemia, and bone lesions.²⁴ In this study, 33.1% of patients exhibited osteolytic bone lesions, 31.9% had anaemia, 21.8% had renal insufficiency and 13.1% had hypercalcemia. A population-based cohort study conducted in the United Kingdom found that 71% of the patients complained of bone pain which was later confirmed to be due to bone lesions.²⁵ Another study conducted in Ghana documented that 76% of the patients had osteolytic bone lesions, 52% had anaemia, 36% had hypercalcemia and 33% had renal insufficiency.²⁶ In addition, research done in the United States indicated that approximately 79% of the patients had osteolytic bone lesions, 73% had anaemia and 19% had renal insufficiency.²⁷ Therefore, results indicate, that the osteolytic bone lesion was the most commonly observed clinical feature, hence patients presenting with unusual and prolonged bone pain without association to any disease should undergo a further clinical examination to rule out multiple myeloma.

The landscape of cancer treatment has undergone significant transformations in recent times, with advancements leading to effective therapies for numerous previously fatal malignancies. Despite these therapeutic triumphs, many antineoplastic agents exhibit a narrow therapeutic index, heightening the risk of adverse effects such as nausea, vomiting, neutropenia, anaemia, pancytopenia, alopecia, constipation, diarrhea, and fatigue¹⁸ Based on the analysis, 81.5% of 151 patients in our setting encountered ADRs. The predominant ADR documented was peripheral neuropathy (21.7%), consistent with previous studies that identified peripheral neuropathy as the primary ADR in MM patients.^28–31 In contrast, other literature findings stated nausea and vomiting as the most prevalent ADRs,^32,33 whereas in our investigation, they ranked as the second most common ADR, occurring in 14.8% of the cases. The incidence is lower when compared to a study which revealed that 90% of individuals receiving highly emetogenic chemotherapy and between 30% and 90% of those undergoing moderately emetogenic chemotherapy experienced nausea and vomiting.³⁴ The curtailed incidence of nausea and vomiting in our study population may be due to pre-emptive premedication with drugs such as ondansetron, and dexamethasone.³³

Other ADRs observed in this study like fatigue, constipation, diarrhoea, and gastritis underscore the importance of proactive measures in mitigating treatment-related side effects. Meticulous premedication strategies, tailored to individual patient needs, can minimize adverse effects. Proactive administration of medications, like stimulants, helps manage chemotherapy-related fatigue. Similarly, prophylactic use of laxatives mitigates constipation, while dietary counselling educates patients on gastrointestinal symptom management. Encouraging fibre-rich foods and hydration strategies enhances treatment tolerance. These measures improve patient outcomes and foster a supportive approach to chemotherapy management.³⁵

The prevalence of chemotherapy-related ADRs in MM patients is significantly influenced by the specific chemotherapy regimen used.³⁶ In our setting, the VRD and VCD regimen had a significant association between the occurrence of severe ADRs and the chemotherapy regimen. The VRD regimen is a potent combination therapy used in the treatment of MM. Studies have shown that VRD is highly effective in both newly diagnosed and relapsed/refractory MM cases.^37,38 VRD has demonstrated a survival benefit compared to other regimens and is considered a preferred choice for bortezomib-based therapy.³⁹ However, despite its efficacy, the VRD regimen is associated with ADRs that can affect patients’ tolerability and adherence to treatment.^40,41 At KNH, VRD was the primary culprit of the majority of ADRs including, peripheral neuropathy (21.2%), nausea and vomiting (13.6%), neutropenia (12.9%), anaemia (12.1%), thrombocytopenia (6.1%) and deep vein thrombosis (1.5%). Although the VRD regimen remains a potent and effective therapy for multiple myeloma, its associated ADRs pose significant challenges to patient tolerability and treatment adherence.⁴² The results of this study indicated that VRD was responsible for the majority of ADRs observed in the study setting. These ADRs mirror those reported in a phase 3 clinical trial conducted across European countries.⁴² To address these challenges, proactive measures, tailored to individual patient needs, can help minimize ADRs and improve treatment tolerability. Additionally, close monitoring and prompt intervention for ADRs are essential to optimize patient outcomes and ensure the continued efficacy of the VRD regimen in the management of multiple myeloma.

The VCD regimen, comprising bortezomib, cyclophosphamide, and dexamethasone, is also a commonly used treatment for MM. Studies have demonstrated that the VCD regimen, in comparison to other regimens like VRD, can effectively induce responses in newly diagnosed transplant-eligible patients.⁴³ The incorporation of cyclophosphamide into the VCD regimen has been linked to high response rates and a favourable side-effect profile.⁴⁴ In the study setting, it was the second regimen causing the most ADRs. In previous studies, cyclophosphamide was documented to cause renal insufficiency, myelosuppression, nausea and vomiting.⁴⁵ The other ADRs linked to bortezomib include peripheral neuropathy, nausea and vomiting, constipation, and fatigue.^30,46,47 The result of this study emphasizes the need for personalized treatment approaches and close monitoring to mitigate treatment-related side effects and optimize therapeutic outcomes for patients on VCD regimens.

Analysis of the severity of ADRs using the Modified Hartwig and Siegel scale showed that 51.7% of ADRs were of moderate severity, 29.8% of ADRs were mild and 18.5% of ADRs were non-assessable. Assessment of the preventability of ADRs by the Schumock and Thornton Scale showed that 68.2% of the ADRs were definitely preventable while 13.2% of ADRs were probably preventable and 18.5% of ADRs were non-assessable. Similarly, a study conducted in Nepal documented that 73.4% of the ADRs were classified as moderate in severity, followed by 20.5% categorized as mild. Severe ADRs constituted only 6.1% of the cases. The study also revealed that 42.7% of the ADRs were definitively preventable, 52.2% were probably preventable, and 5.1% were deemed non-preventable.⁴⁸ In contrast, a retrospective cohort study demonstrated that the majority of ADRs were categorized as mild (54.45%), with the remaining cases being moderate (44.50%) and severe (1.04%). The study indicated that the majority of ADRs (174 cases) were preventable, while only a small number (17 patients) were considered not preventable.⁴⁹ This highlights the critical role of comprehensive patient care and underscores the ongoing need for vigilant monitoring and intervention to optimize the efficacy and safety of cancer treatment regimens to mitigate preventable ADRs.

Previous studies have reported that women have been found to experience twice the incidence of ADRs compared to men. Women are at a higher risk of experiencing chemotherapy-related ADRs due to biological differences affecting the drug pharmacokinetics.^50,51 Conversely, some studies have reported conflicting findings, suggesting that gender may not play a significant role in the prevalence of chemotherapy-related ADRs.^18,52 These variations in research findings underscore the complexity of the relationship between gender and chemotherapy-related ADRs, indicating the need for further investigation and consideration of multiple factors influencing ADRS in cancer patients.

Studies have highlighted the role of disease-related factors in the development of not only ADRs but also second malignancies after MM treatment.⁵³ Comorbidities such as hypertension, diabetes, chronic kidney disease, heart failure, deep vein thrombosis, and retroviral disease can significantly impact the chances of experiencing chemotherapy-related ADRs in patients with multiple myeloma.⁵⁴ Almost two-thirds (62.9%) of the patients in our setting have pre-existing comorbidities, which increase their susceptibility to treatment toxicities due to a higher incidence of underlying health conditions and diminished physiological reserve.¹¹ Patients with chronic kidney disease are particularly vulnerable to ADRs as they are usually on multiple drug regimens and have altered pharmacokinetics and pharmacodynamic parameters.⁵⁵ Additionally, patients with heart failure, hypertension, and diabetes are at an increased risk of developing contrast-induced nephrotoxicity, which can further exacerbate kidney-related complications during chemotherapy, leading to unplanned hospitalizations and poorer outcomes.⁵⁶

In relation to age, research indicates that the incidence and severity of ADRs can vary depending on the age of the patient undergoing chemotherapy.^36,57,58 Older adults, in particular, may experience distinct treatment-related effects due to age-related changes in physiology and pharmacokinetics.⁵⁷

Research has shown that there are sex differences in the incidence of chemotherapy-related ADRs, with female patients tending to experience a higher frequency of such reactions due to biological dissimilarities affecting drug pharmacokinetics between genders.⁵⁹ Understanding these gender-specific differences is crucial in optimizing treatment strategies and managing ADRs effectively. Despite several studies reporting different factors were affecting the occurrence of ADRs in cancer patients, the presence of comorbidities, educational level, age, and gender were not significant predictors of ADRs in our setting.

Moving forward, comprehensive approaches integrating demographic, clinical, and pharmacological considerations are essential for optimizing MM management and improving patient outcomes. Further research is warranted to elucidate the complex interplay of factors influencing ADRs in MM patients and to inform personalized therapeutic interventions.

Limitations of the study

The research methodology employed in the study was retrospective, depending on the accurate recording of medical records, which was deficient, indicated by a notable proportion of absent data. Consequently, this led to a limited sample size due to the failure to achieve the anticipated sample population.

The identification of ADRs caused by individual chemotherapeutic agents proved challenging when administered concurrently. Consequently, our research was unable to pinpoint the primary chemotherapeutic drug responsible for the majority of ADRs.

Conclusion

Overall, the incidence of chemotherapy-related ADRs in MM patients in our setting was notably high (81.5%). Despite the moderate severity of the ADRs, their preventable nature highlights the potential for improved patient outcomes through careful regimen selection and monitoring. Analysis using both univariable and multivariable binary logistic regression models indicated that VRD and VCD regimens were the significant factors affecting the occurrence of ADRs. Hence, there is a need for vigilant chemotherapy-related ADR reporting and documentation, to promote early prevention, detection, and management and decrease morbidity and mortality due to ADRs.

Footnotes

Acknowledgements

The authors would like to acknowledge the United States International University-Africa School of Pharmacy and Health Sciences and Kenyatta National Hospital in Kenya for supporting this research.

Authors’ contributions

EAA, AD and CAO were involved from the conception to the final manuscript preparation. All authors reviewed and approved the manuscript.

Data availability

The data is available from the corresponding author upon request

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Research ethics and patient consent

The study was approved by the Ethics and Research Committee of the University of Nairobi/KNH (Approval No: KNH-ERC/UA/359). Stringent data privacy standards were upheld to ensure patient confidentiality. To safeguard this confidentiality, participants were referenced by their initials and assigned a distinctive identification number. Written informed consent was obtained from all the study participants before the study.

ORCID iDs

Epifania Amedeus Assenga

Amsalu Degu

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