Trial Outcomes & Findings for Lenalidomide and Vaccine Therapy in Treating Patients With Early-Stage Asymptomatic Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT01351896)

NCT ID: NCT01351896

Last Updated: 2025-11-20

Results Overview

Defined as achieving at least a four-fold increase in post-vaccination serotype-specific immunoglobulin G (IgG) titers or serotype-specific IgG concentrations of \>= 0.35 ug/mL for 6 of 7 serotypes measured by a standard enzyme linked immunosorbent assay.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 49 participants
• Primary outcome timeframe: Up to 1 month
• Results posted on: 2025-11-20

Participant Flow

Participant milestones

Measure	Arm A (Concurrent PCV13 and Lenalidomide) Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm B (Sequential PCV13 and Lenalidomide) Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Overall Study STARTED	24	25
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lenalidomide and Vaccine Therapy in Treating Patients With Early-Stage Asymptomatic Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Baseline characteristics by cohort

Measure	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Total n=49 Participants Total of all reporting groups
Age, Continuous	61 years	57 years n=4 Participants	59 years n=8 Participants
Sex: Female, Male Female	8 Participants	7 Participants n=4 Participants	15 Participants n=8 Participants
Sex: Female, Male Male	16 Participants	18 Participants n=4 Participants	34 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants	25 Participants n=4 Participants	49 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants	0 Participants n=4 Participants	1 Participants n=8 Participants
Race (NIH/OMB) White	22 Participants	25 Participants n=4 Participants	47 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants n=4 Participants	1 Participants n=8 Participants
Region of Enrollment United States	24 participants	25 participants n=4 Participants	49 participants n=8 Participants

PRIMARY outcome

Timeframe: Up to 1 month

Defined as achieving at least a four-fold increase in post-vaccination serotype-specific immunoglobulin G (IgG) titers or serotype-specific IgG concentrations of >= 0.35 ug/mL for 6 of 7 serotypes measured by a standard enzyme linked immunosorbent assay.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Proportion of Patients Who Achieve an Antibody Response	88 percentage of participants	75 percentage of participants

SECONDARY outcome

Timeframe: Up to 4 years

Summarized using descriptive statistics by treatment arm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 2 years

Population: The number of participants analyzed for complete response at 2 years is the number of participants for whom response data was available at the 2 year mark.

95% confidence intervals will be estimated. A designation of complete response (CR) requires all of the following for a period of at least two months from completion of therapy:

• Absence of adenopathy on physical exam.
• No hepatomegaly or splenomegaly on physical exam.
• Absence of constitutional symptoms.
• Normal CBC as exhibited by polymorphonuclear leukocytes ≥ 1500/µL, platelets > 100,000/µL, hemoglobin > 11.0 g/dL (untransfused), and lymphocyte count < 5,000/ µL.
• Bone marrow aspirate and biopsy must be normocellular for age with < 30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. If the marrow is hypocellular, a repeat determination should be performed in one month.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=20 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=16 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Complete Response Rate	0 percentage of participants Interval 0.0 to 17.0	6 percentage of participants Interval 0.2 to 30.0

SECONDARY outcome

Timeframe: From study entry to first therapy for progressive CLL, assessed up to 4 years

Defined by International Workshop on chronic lymphocytic leukemia (CLL) (IWCLL) 2008 criteria. Summarized and explored between treatment arms using Kaplan-Meier methods. Reported as the probability of not starting the next treatment and its 95% CI for each year.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Time to First Treatment Year 1	0.96 probabibility rate Interval 0.75 to 0.99	0.88 probabibility rate Interval 0.66 to 0.96
Time to First Treatment Year 2	0.92 probabibility rate Interval 0.72 to 0.98	0.79 probabibility rate Interval 0.57 to 0.91
Time to First Treatment Year 3	0.80 probabibility rate Interval 0.58 to 0.91	0.79 probabibility rate Interval 0.57 to 0.91
Time to First Treatment Year 4	0.70 probabibility rate Interval 0.46 to 0.85	0.74 probabibility rate Interval 0.51 to 0.88

SECONDARY outcome

Timeframe: Up to 4 years

Summarized and explored between treatment arms using Kaplan-Meier methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from start of treatment to time of disease progression or death secondary to any cause, assessed up to 2 years

Defined by International Workshop on chronic lymphocytic leukemia (CLL) (IWCLL) 2008 criteria. Summarized and explored between treatment arms using Kaplan-Meier methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 4 years

Summarized by and across treatment arms, along with the type, severity, and perceived attribution to study according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5. The rates of severe (grade 3+) toxicity (at least possibly related to treatment) and non-hematologic toxicity will be summarized; assuming the incidence of severe toxicity is binomially distributed, 95% confidence intervals will be calculated. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine the toxicity patterns. Adverse events occurring in greater than 5% of the participants in each arm will be reported in this outcome measure.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Number of Adverse Events Anemia	38 Number of Events	46 Number of Events
Number of Adverse Events Mucositis oral	6 Number of Events	0 Number of Events
Number of Adverse Events Bronchial infection	4 Number of Events	1 Number of Events
Number of Adverse Events Sinusitis	9 Number of Events	10 Number of Events
Number of Adverse Events Urinary tract infection	4 Number of Events	5 Number of Events
Number of Adverse Events Alkaline phosphatase increased	7 Number of Events	10 Number of Events
Number of Adverse Events Creatinine increased	26 Number of Events	29 Number of Events
Number of Adverse Events Lymphocyte count increased	35 Number of Events	25 Number of Events
Number of Adverse Events Neutrophil count decreased	100 Number of Events	119 Number of Events
Number of Adverse Events Weight gain	2 Number of Events	2 Number of Events
Number of Adverse Events Dehydration	1 Number of Events	4 Number of Events
Number of Adverse Events Hyperuricemia	37 Number of Events	14 Number of Events
Number of Adverse Events Hypocalcemia	18 Number of Events	22 Number of Events
Number of Adverse Events Hypokalemia	22 Number of Events	28 Number of Events
Number of Adverse Events Hypomagnesemia	3 Number of Events	2 Number of Events
Number of Adverse Events Hyponatremia	11 Number of Events	8 Number of Events
Number of Adverse Events Hypophosphatemia	58 Number of Events	15 Number of Events
Number of Adverse Events Dizziness	10 Number of Events	7 Number of Events
Number of Adverse Events Dysesthesia	9 Number of Events	11 Number of Events
Number of Adverse Events Sinus pain	2 Number of Events	0 Number of Events
Number of Adverse Events Insomnia	5 Number of Events	5 Number of Events
Number of Adverse Events Epistaxis	1 Number of Events	2 Number of Events
Number of Adverse Events Rash acneiform	0 Number of Events	6 Number of Events
Number of Adverse Events Leukocytosis	9 Number of Events	3 Number of Events
Number of Adverse Events Lymph node pain	10 Number of Events	7 Number of Events
Number of Adverse Events Cardiac disorders, other	2 Number of Events	2 Number of Events
Number of Adverse Events Palpitations	3 Number of Events	0 Number of Events
Number of Adverse Events Sinus bradycardia	21 Number of Events	18 Number of Events
Number of Adverse Events Sinus tachycardia	2 Number of Events	2 Number of Events
Number of Adverse Events Ear and labyrinth disorders, other	3 Number of Events	1 Number of Events
Number of Adverse Events Ear pain	4 Number of Events	1 Number of Events
Number of Adverse Events Tinnitus	2 Number of Events	1 Number of Events
Number of Adverse Events Vertigo	2 Number of Events	1 Number of Events
Number of Adverse Events Dry eye	1 Number of Events	2 Number of Events
Number of Adverse Events Eye disorders, other	4 Number of Events	1 Number of Events
Number of Adverse Events Floaters	1 Number of Events	2 Number of Events
Number of Adverse Events Abdominal pain	12 Number of Events	3 Number of Events
Number of Adverse Events Bloating	7 Number of Events	1 Number of Events
Number of Adverse Events Constipation	16 Number of Events	14 Number of Events
Number of Adverse Events Dental caries	4 Number of Events	0 Number of Events
Number of Adverse Events Diarrhea	63 Number of Events	42 Number of Events
Number of Adverse Events Dyspepsia	7 Number of Events	2 Number of Events
Number of Adverse Events Flatulence	1 Number of Events	3 Number of Events
Number of Adverse Events Gastroesophageal reflux disease	3 Number of Events	5 Number of Events
Number of Adverse Events Gastrointestinal disorders, other	5 Number of Events	4 Number of Events
Number of Adverse Events Nausea	16 Number of Events	10 Number of Events
Number of Adverse Events Oral pain	5 Number of Events	4 Number of Events
Number of Adverse Events Toothache	2 Number of Events	2 Number of Events
Number of Adverse Events Vomiting	8 Number of Events	2 Number of Events
Number of Adverse Events Chills	0 Number of Events	2 Number of Events
Number of Adverse Events Edema limbs	4 Number of Events	3 Number of Events
Number of Adverse Events Fatigue	21 Number of Events	11 Number of Events
Number of Adverse Events Fever	9 Number of Events	6 Number of Events
Number of Adverse Events Flu like symptoms	2 Number of Events	4 Number of Events
Number of Adverse Events Localized edema	9 Number of Events	7 Number of Events
Number of Adverse Events Non-cardiac chest pain	3 Number of Events	3 Number of Events
Number of Adverse Events Pain	8 Number of Events	9 Number of Events
Number of Adverse Events Gallbladder pain	0 Number of Events	3 Number of Events
Number of Adverse Events Infections and infestations, other	5 Number of Events	4 Number of Events
Number of Adverse Events Lung infection	1 Number of Events	9 Number of Events
Number of Adverse Events Nail infection	3 Number of Events	2 Number of Events
Number of Adverse Events Papulopustular rash	2 Number of Events	1 Number of Events
Number of Adverse Events Prostate infection	2 Number of Events	0 Number of Events
Number of Adverse Events Skin infection	2 Number of Events	7 Number of Events
Number of Adverse Events Upper respiratory infection	21 Number of Events	23 Number of Events
Number of Adverse Events Vaginal infection	0 Number of Events	3 Number of Events
Number of Adverse Events Bruising	14 Number of Events	4 Number of Events
Number of Adverse Events Fall	8 Number of Events	3 Number of Events
Number of Adverse Events Injury, poisoning and procedural complications, other	0 Number of Events	2 Number of Events
Number of Adverse Events Alanine aminotransferase increased	34 Number of Events	28 Number of Events
Number of Adverse Events Aspartate aminotransferase increased	27 Number of Events	28 Number of Events
Number of Adverse Events Blood bilirubin increased	37 Number of Events	25 Number of Events
Number of Adverse Events Hemoglobin increased	3 Number of Events	0 Number of Events
Number of Adverse Events Lymphocyte count decreased	21 Number of Events	25 Number of Events
Number of Adverse Events Platelet count decreased	66 Number of Events	67 Number of Events
Number of Adverse Events Weight loss	13 Number of Events	7 Number of Events
Number of Adverse Events White blood cell decreased	28 Number of Events	57 Number of Events
Number of Adverse Events Anorexia	3 Number of Events	1 Number of Events
Number of Adverse Events Hypercalcemia	7 Number of Events	4 Number of Events
Number of Adverse Events Hyperglycemia	117 Number of Events	94 Number of Events
Number of Adverse Events Hyperkalemia	6 Number of Events	2 Number of Events
Number of Adverse Events Hypernatremia	2 Number of Events	1 Number of Events
Number of Adverse Events Hypoalbuminemia	12 Number of Events	3 Number of Events
Number of Adverse Events Hypoglycemia	18 Number of Events	7 Number of Events
Number of Adverse Events Metabolism and nutrition disorders, other	2 Number of Events	0 Number of Events
Number of Adverse Events Arthralgia	10 Number of Events	7 Number of Events
Number of Adverse Events Arthritis	2 Number of Events	1 Number of Events
Number of Adverse Events Back pain	7 Number of Events	10 Number of Events
Number of Adverse Events Musculoskeletal and connective tissue disorder, other	3 Number of Events	4 Number of Events
Number of Adverse Events Myalgia	14 Number of Events	9 Number of Events
Number of Adverse Events Pain in extremity	8 Number of Events	4 Number of Events
Number of Adverse Events Neoplasms, benign, malignant and unspecified, other	10 Number of Events	6 Number of Events
Number of Adverse Events Dysgeusia	1 Number of Events	3 Number of Events
Number of Adverse Events Headache	29 Number of Events	19 Number of Events
Number of Adverse Events Paresthesia	5 Number of Events	5 Number of Events
Number of Adverse Events Presyncope	3 Number of Events	3 Number of Events
Number of Adverse Events Anxiety	2 Number of Events	0 Number of Events
Number of Adverse Events Confusion	2 Number of Events	2 Number of Events
Number of Adverse Events Depression	2 Number of Events	0 Number of Events
Number of Adverse Events Chronic kidney disease	2 Number of Events	6 Number of Events
Number of Adverse Events Hematuria	2 Number of Events	0 Number of Events
Number of Adverse Events Renal calculi	2 Number of Events	0 Number of Events
Number of Adverse Events Allergic rhinitis	10 Number of Events	13 Number of Events
Number of Adverse Events Cough	27 Number of Events	14 Number of Events
Number of Adverse Events Dyspnea	15 Number of Events	9 Number of Events
Number of Adverse Events Hoarseness	3 Number of Events	1 Number of Events
Number of Adverse Events Laryngeal inflammation	2 Number of Events	1 Number of Events
Number of Adverse Events Nasal congestion	5 Number of Events	7 Number of Events
Number of Adverse Events Postnasal drip	12 Number of Events	1 Number of Events
Number of Adverse Events Productive cough	10 Number of Events	6 Number of Events
Number of Adverse Events Respiratory, thoracic and mediastinal disorders, other	6 Number of Events	1 Number of Events
Number of Adverse Events Sore throat	20 Number of Events	11 Number of Events
Number of Adverse Events Hyperhidrosis	5 Number of Events	1 Number of Events
Number of Adverse Events Pruritus	2 Number of Events	3 Number of Events
Number of Adverse Events Rash maculo-papular	19 Number of Events	27 Number of Events
Number of Adverse Events Skin and subcutaneous tissue disorders, other	32 Number of Events	40 Number of Events
Number of Adverse Events Flushing	2 Number of Events	2 Number of Events
Number of Adverse Events Hypertension	90 Number of Events	80 Number of Events

SECONDARY outcome

Timeframe: Baseline, days 1 and 2 of course 2 (Arm A) and days 1 and 2 of course 5 (Arm B)

PK will be graphically evaluated within and across arms to assess potential patterns and relationships.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 4 years

Pharmacodynamic markers will be graphically evaluated within and across arms to assess potential patterns and relationships.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 4 years

Pharmacodynamic markers will be graphically evaluated within and across arms to assess potential patterns and relationships.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 1 Cycle 4 day 1	17.2 micrograms per milliliter Standard Deviation 28.2	—
Antibody Titre Levels for Serotype 1 Cycle 5 day 1	—	18.2 micrograms per milliliter Standard Deviation 56.1
Antibody Titre Levels for Serotype 1 Cycle 6 day 1	—	16.9 micrograms per milliliter Standard Deviation 45.0
Antibody Titre Levels for Serotype 1 Cycle 10 day 1	7.9 micrograms per milliliter Standard Deviation 10.4	—
Antibody Titre Levels for Serotype 1 Cycle 1 day 1	7.4 micrograms per milliliter Standard Deviation 15.2	4.1 micrograms per milliliter Standard Deviation 8.1
Antibody Titre Levels for Serotype 1 Cycle 3 day 1	10.1 micrograms per milliliter Standard Deviation 18.7	13.8 micrograms per milliliter Standard Deviation 47.1

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 2 Cycle 1 day 1	1.5 micrograms per milliliter Standard Deviation 1.2	1.8 micrograms per milliliter Standard Deviation 2.0
Antibody Titre Levels for Serotype 2 Cycle 3 day 1	1.7 micrograms per milliliter Standard Deviation 1.8	1.7 micrograms per milliliter Standard Deviation 2.0
Antibody Titre Levels for Serotype 2 Cycle 4 day 1	1.8 micrograms per milliliter Standard Deviation 1.7	—
Antibody Titre Levels for Serotype 2 Cycle 5 day 1	—	2.5 micrograms per milliliter Standard Deviation 3.0
Antibody Titre Levels for Serotype 2 Cycle 6 day 1	—	2.0 micrograms per milliliter Standard Deviation 2.3
Antibody Titre Levels for Serotype 2 Cycle 10 day 1	1.6 micrograms per milliliter Standard Deviation 1.2	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 3 Cycle 1 day 1	2.9 micrograms per milliliter Standard Deviation 5.4	2.0 micrograms per milliliter Standard Deviation 1.6
Antibody Titre Levels for Serotype 3 Cycle 3 day 1	11.1 micrograms per milliliter Standard Deviation 32.0	2.1 micrograms per milliliter Standard Deviation 2.0
Antibody Titre Levels for Serotype 3 Cycle 4 day 1	20.1 micrograms per milliliter Standard Deviation 58.0	—
Antibody Titre Levels for Serotype 3 Cycle 5 day 1	—	3.0 micrograms per milliliter Standard Deviation 2.6
Antibody Titre Levels for Serotype 3 Cycle 6 day 1	—	9.5 micrograms per milliliter Standard Deviation 12.3
Antibody Titre Levels for Serotype 3 Cycle 10 day 1	6.5 micrograms per milliliter Standard Deviation 14.6	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 4 Cycle 1 day 1	1.4 micrograms per milliliter Standard Deviation 2.0	0.5 micrograms per milliliter Standard Deviation 0.5
Antibody Titre Levels for Serotype 4 Cycle 3 day 1	11.8 micrograms per milliliter Standard Deviation 50.8	0.6 micrograms per milliliter Standard Deviation 0.6
Antibody Titre Levels for Serotype 4 Cycle 4 day 1	18.3 micrograms per milliliter Standard Deviation 53.1	—
Antibody Titre Levels for Serotype 4 Cycle 5 day 1	—	0.9 micrograms per milliliter Standard Deviation 0.9
Antibody Titre Levels for Serotype 4 Cycle 6 day 1	—	6.1 micrograms per milliliter Standard Deviation 11.8
Antibody Titre Levels for Serotype 4 Cycle 10 day 1	8.9 micrograms per milliliter Standard Deviation 25.1	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 5 Cycle 1 day 1	4.4 micrograms per milliliter Standard Deviation 5.8	2.7 micrograms per milliliter Standard Deviation 2.6
Antibody Titre Levels for Serotype 5 Cycle 3 day 1	16.0 micrograms per milliliter Standard Deviation 26.4	3.0 micrograms per milliliter Standard Deviation 2.8
Antibody Titre Levels for Serotype 5 Cycle 4 day 1	27.0 micrograms per milliliter Standard Deviation 39.6	—
Antibody Titre Levels for Serotype 5 Cycle 5 day 1	—	11.0 micrograms per milliliter Standard Deviation 23.3
Antibody Titre Levels for Serotype 5 Cycle 6 day 1	—	12.9 micrograms per milliliter Standard Deviation 17.2
Antibody Titre Levels for Serotype 5 Cycle 10 day 1	30.1 micrograms per milliliter Standard Deviation 52.8	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 8 Cycle 6 day 1	—	2.2 micrograms per milliliter Standard Deviation 2.5
Antibody Titre Levels for Serotype 8 Cycle 10 day 1	2.1 micrograms per milliliter Standard Deviation 2.4	—
Antibody Titre Levels for Serotype 8 Cycle 1 day 1	2.0 micrograms per milliliter Standard Deviation 2.0	2.3 micrograms per milliliter Standard Deviation 3.0
Antibody Titre Levels for Serotype 8 Cycle 3 day 1	3.2 micrograms per milliliter Standard Deviation 5.5	2.1 micrograms per milliliter Standard Deviation 2.5
Antibody Titre Levels for Serotype 8 Cycle 5 day 1	—	2.9 micrograms per milliliter Standard Deviation 3.7
Antibody Titre Levels for Serotype 8 Cycle 4 day 1	3.4 micrograms per milliliter Standard Deviation 6.6	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 9N Cycle 1 day 1	2.9 micrograms per milliliter Standard Deviation 3.5	1.7 micrograms per milliliter Standard Deviation 1.5
Antibody Titre Levels for Serotype 9N Cycle 3 day 1	5.2 micrograms per milliliter Standard Deviation 12.5	2.0 micrograms per milliliter Standard Deviation 2.4
Antibody Titre Levels for Serotype 9N Cycle 4 day 1	8.7 micrograms per milliliter Standard Deviation 24.5	—
Antibody Titre Levels for Serotype 9N Cycle 5 day 1	—	2.7 micrograms per milliliter Standard Deviation 3.9
Antibody Titre Levels for Serotype 9N Cycle 6 day 1	—	3.1 micrograms per milliliter Standard Deviation 4.9
Antibody Titre Levels for Serotype 9N Cycle 10 day 1	5.3 micrograms per milliliter Standard Deviation 10.8	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 12F Cycle 1 day 1	0.9 micrograms per milliliter Standard Deviation 1.1	0.7 micrograms per milliliter Standard Deviation 0.8
Antibody Titre Levels for Serotype 12F Cycle 3 day 1	1.3 micrograms per milliliter Standard Deviation 1.4	0.7 micrograms per milliliter Standard Deviation 0.8
Antibody Titre Levels for Serotype 12F Cycle 4 day 1	1.2 micrograms per milliliter Standard Deviation 1.4	—
Antibody Titre Levels for Serotype 12F Cycle 5 day 1	—	0.9 micrograms per milliliter Standard Deviation 0.9
Antibody Titre Levels for Serotype 12F Cycle 6 day 1	—	0.7 micrograms per milliliter Standard Deviation 0.6
Antibody Titre Levels for Serotype 12F Cycle 10 day 1	0.9 micrograms per milliliter Standard Deviation 0.9	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 14 Cycle 1 day 1	1.4 micrograms per milliliter Standard Deviation 2.0	0.5 micrograms per milliliter Standard Deviation 0.5
Antibody Titre Levels for Serotype 14 Cycle 3 day 1	11.8 micrograms per milliliter Standard Deviation 50.8	0.6 micrograms per milliliter Standard Deviation 0.6
Antibody Titre Levels for Serotype 14 Cycle 4 day 1	18.3 micrograms per milliliter Standard Deviation 53.1	—
Antibody Titre Levels for Serotype 14 Cycle 5 day 1	—	0.9 micrograms per milliliter Standard Deviation 0.9
Antibody Titre Levels for Serotype 14 Cycle 6 day 1	—	6.1 micrograms per milliliter Standard Deviation 11.8
Antibody Titre Levels for Serotype 14 Cycle 10 day 1	8.9 micrograms per milliliter Standard Deviation 25.1	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 17F Cycle 1 day 1	5.2 micrograms per milliliter Standard Deviation 5.7	9.7 micrograms per milliliter Standard Deviation 15.1
Antibody Titre Levels for Serotype 17F Cycle 3 day 1	6.0 micrograms per milliliter Standard Deviation 8.7	9.0 micrograms per milliliter Standard Deviation 13.2
Antibody Titre Levels for Serotype 17F Cycle 4 day 1	6.0 micrograms per milliliter Standard Deviation 8.5	—
Antibody Titre Levels for Serotype 17F Cycle 5 day 1	—	14.4 micrograms per milliliter Standard Deviation 20.2
Antibody Titre Levels for Serotype 17F Cycle 6 day 1	—	11.6 micrograms per milliliter Standard Deviation 18.4
Antibody Titre Levels for Serotype 17F Cycle 10 day 1	4.2 micrograms per milliliter Standard Deviation 5.0	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 19F Cycle 1 day 1	6.1 micrograms per milliliter Standard Deviation 15.3	3.5 micrograms per milliliter Standard Deviation 3.6
Antibody Titre Levels for Serotype 19F Cycle 3 day 1	13.3 micrograms per milliliter Standard Deviation 29.6	6.3 micrograms per milliliter Standard Deviation 14.2
Antibody Titre Levels for Serotype 19F Cycle 4 day 1	34.5 micrograms per milliliter Standard Deviation 68.8	—
Antibody Titre Levels for Serotype 19F Cycle 5 day 1	—	13.6 micrograms per milliliter Standard Deviation 24.1
Antibody Titre Levels for Serotype 19F Cycle 6 day 1	—	24.7 micrograms per milliliter Standard Deviation 37.0
Antibody Titre Levels for Serotype 19F Cycle 10 day 1	14.7 micrograms per milliliter Standard Deviation 20.3	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 20 Cycle 1 day 1	1.9 micrograms per milliliter Standard Deviation 2.3	2.0 micrograms per milliliter Standard Deviation 4.4
Antibody Titre Levels for Serotype 20 Cycle 3 day 1	1.8 micrograms per milliliter Standard Deviation 2.2	1.9 micrograms per milliliter Standard Deviation 3.9
Antibody Titre Levels for Serotype 20 Cycle 4 day 1	2.1 micrograms per milliliter Standard Deviation 2.1	—
Antibody Titre Levels for Serotype 20 Cycle 5 day 1	—	3.2 micrograms per milliliter Standard Deviation 5.5
Antibody Titre Levels for Serotype 20 Cycle 6 day 1	—	2.1 micrograms per milliliter Standard Deviation 3.8
Antibody Titre Levels for Serotype 20 Cycle 10 day 1	1.5 micrograms per milliliter Standard Deviation 1.6	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 22F Cycle 1 day 1	10.2 micrograms per milliliter Standard Deviation 11.8	8.0 micrograms per milliliter Standard Deviation 7.7
Antibody Titre Levels for Serotype 22F Cycle 3 day 1	11.1 micrograms per milliliter Standard Deviation 16.7	9.2 micrograms per milliliter Standard Deviation 12.9
Antibody Titre Levels for Serotype 22F Cycle 4 day 1	11.5 micrograms per milliliter Standard Deviation 16.0	—
Antibody Titre Levels for Serotype 22F Cycle 5 day 1	—	11.9 micrograms per milliliter Standard Deviation 16.8
Antibody Titre Levels for Serotype 22F Cycle 6 day 1	—	10.7 micrograms per milliliter Standard Deviation 15.3
Antibody Titre Levels for Serotype 22F Cycle 10 day 1	10.3 micrograms per milliliter Standard Deviation 14.8	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 23F Cycle 1 day 1	15.9 micrograms per milliliter Standard Deviation 26.7	10.2 micrograms per milliliter Standard Deviation 14.6
Antibody Titre Levels for Serotype 23F Cycle 3 day 1	31.5 micrograms per milliliter Standard Deviation 51.2	9.4 micrograms per milliliter Standard Deviation 12.1
Antibody Titre Levels for Serotype 23F Cycle 4 day 1	45.3 micrograms per milliliter Standard Deviation 76.2	—
Antibody Titre Levels for Serotype 23F Cycle 5 day 1	—	12.7 micrograms per milliliter Standard Deviation 17.2
Antibody Titre Levels for Serotype 23F Cycle 6 day 1	—	17.0 micrograms per milliliter Standard Deviation 24.8
Antibody Titre Levels for Serotype 23F Cycle 10 day 1	23.8 micrograms per milliliter Standard Deviation 38.9	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 6B Cycle 1 day 1	6.7 micrograms per milliliter Standard Deviation 9.1	3.0 micrograms per milliliter Standard Deviation 2.9
Antibody Titre Levels for Serotype 6B Cycle 3 day 1	38.8 micrograms per milliliter Standard Deviation 101.9	4.2 micrograms per milliliter Standard Deviation 5.0
Antibody Titre Levels for Serotype 6B Cycle 4 day 1	60.2 micrograms per milliliter Standard Deviation 114.4	—
Antibody Titre Levels for Serotype 6B Cycle 5 day 1	—	9.0 micrograms per milliliter Standard Deviation 14.4
Antibody Titre Levels for Serotype 6B Cycle 6 day 1	—	17.8 micrograms per milliliter Standard Deviation 26.5
Antibody Titre Levels for Serotype 6B Cycle 10 day 1	31.9 micrograms per milliliter Standard Deviation 50.6	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 10A Cycle 4 day 1	4.7 micrograms per milliliter Standard Deviation 5.4	—
Antibody Titre Levels for Serotype 10A Cycle 3 day 1	5.0 micrograms per milliliter Standard Deviation 5.7	6.7 micrograms per milliliter Standard Deviation 14.2
Antibody Titre Levels for Serotype 10A Cycle 1 day 1	4.7 micrograms per milliliter Standard Deviation 5.7	5.5 micrograms per milliliter Standard Deviation 11.6
Antibody Titre Levels for Serotype 10A Cycle 5 day 1	—	8.6 micrograms per milliliter Standard Deviation 15.5
Antibody Titre Levels for Serotype 10A Cycle 6 day 1	—	6.9 micrograms per milliliter Standard Deviation 12.9
Antibody Titre Levels for Serotype 10A Cycle 10 day 1	4.2 micrograms per milliliter Standard Deviation 5.1	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 11A Cycle 5 day 1	—	2.3 micrograms per milliliter Standard Deviation 2.9
Antibody Titre Levels for Serotype 11A Cycle 6 day 1	—	1.9 micrograms per milliliter Standard Deviation 2.2
Antibody Titre Levels for Serotype 11A Cycle 10 day 1	1.7 micrograms per milliliter Standard Deviation 2.3	—
Antibody Titre Levels for Serotype 11A Cycle 1 day 1	1.5 micrograms per milliliter Standard Deviation 1.6	2.1 micrograms per milliliter Standard Deviation 2.8
Antibody Titre Levels for Serotype 11A Cycle 3 day 1	1.6 micrograms per milliliter Standard Deviation 1.7	2.0 micrograms per milliliter Standard Deviation 2.7
Antibody Titre Levels for Serotype 11A Cycle 4 day 1	1.8 micrograms per milliliter Standard Deviation 2.0	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 7F Cycle 1 day 1	7.6 micrograms per milliliter Standard Deviation 15.7	5.1 micrograms per milliliter Standard Deviation 6.6
Antibody Titre Levels for Serotype 7F Cycle 3 day 1	9.9 micrograms per milliliter Standard Deviation 20.1	4.9 micrograms per milliliter Standard Deviation 6.3
Antibody Titre Levels for Serotype 7F Cycle 4 day 1	17.0 micrograms per milliliter Standard Deviation 47.1	—
Antibody Titre Levels for Serotype 7F Cycle 5 day 1	—	6.4 micrograms per milliliter Standard Deviation 6.0
Antibody Titre Levels for Serotype 7F Cycle 6 day 1	—	5.7 micrograms per milliliter Standard Deviation 5.3
Antibody Titre Levels for Serotype 7F Cycle 10 day 1	12.2 micrograms per milliliter Standard Deviation 25.8	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 15B Cycle 1 day 1	4.4 micrograms per milliliter Standard Deviation 12.9	3.2 micrograms per milliliter Standard Deviation 6.9
Antibody Titre Levels for Serotype 15B Cycle 3 day 1	4.0 micrograms per milliliter Standard Deviation 10.2	3.3 micrograms per milliliter Standard Deviation 8.1
Antibody Titre Levels for Serotype 15B Cycle 4 day 1	4.7 micrograms per milliliter Standard Deviation 13.1	—
Antibody Titre Levels for Serotype 15B Cycle 5 day 1	—	4.3 micrograms per milliliter Standard Deviation 8.2
Antibody Titre Levels for Serotype 15B Cycle 6 day 1	—	3.7 micrograms per milliliter Standard Deviation 6.7
Antibody Titre Levels for Serotype 15B Cycle 10 day 1	4.2 micrograms per milliliter Standard Deviation 11.0	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 18C Cycle 1 day 1	3.8 micrograms per milliliter Standard Deviation 7.9	2.6 micrograms per milliliter Standard Deviation 4.8
Antibody Titre Levels for Serotype 18C Cycle 3 day 1	5.6 micrograms per milliliter Standard Deviation 8.8	3.8 micrograms per milliliter Standard Deviation 9.6
Antibody Titre Levels for Serotype 18C Cycle 4 day 1	10.6 micrograms per milliliter Standard Deviation 21.1	—
Antibody Titre Levels for Serotype 18C Cycle 5 day 1	—	3.5 micrograms per milliliter Standard Deviation 4.9
Antibody Titre Levels for Serotype 18C Cycle 6 day 1	—	9.6 micrograms per milliliter Standard Deviation 25.6
Antibody Titre Levels for Serotype 18C Cycle 10 day 1	6.7 micrograms per milliliter Standard Deviation 14.6	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 19A Cycle 1 day 1	7.0 micrograms per milliliter Standard Deviation 10.6	6.9 micrograms per milliliter Standard Deviation 10.4
Antibody Titre Levels for Serotype 19A Cycle 3 day 1	21.7 micrograms per milliliter Standard Deviation 63.4	5.3 micrograms per milliliter Standard Deviation 7.4
Antibody Titre Levels for Serotype 19A Cycle 4 day 1	37.0 micrograms per milliliter Standard Deviation 92.9	—
Antibody Titre Levels for Serotype 19A Cycle 5 day 1	—	9.2 micrograms per milliliter Standard Deviation 9.6
Antibody Titre Levels for Serotype 19A Cycle 6 day 1	—	12.2 micrograms per milliliter Standard Deviation 13.6
Antibody Titre Levels for Serotype 19A Cycle 10 day 1	18.8 micrograms per milliliter Standard Deviation 35.7	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 9V Cycle 1 day 1	4.5 micrograms per milliliter Standard Deviation 5.4	3.7 micrograms per milliliter Standard Deviation 5.6
Antibody Titre Levels for Serotype 9V Cycle 3 day 1	13.5 micrograms per milliliter Standard Deviation 30.1	4.0 micrograms per milliliter Standard Deviation 7.0
Antibody Titre Levels for Serotype 9V Cycle 4 day 1	14.1 micrograms per milliliter Standard Deviation 32.8	—
Antibody Titre Levels for Serotype 9V Cycle 5 day 1	—	7.0 micrograms per milliliter Standard Deviation 13.3
Antibody Titre Levels for Serotype 9V Cycle 6 day 1	—	6.3 micrograms per milliliter Standard Deviation 11.0
Antibody Titre Levels for Serotype 9V Cycle 10 day 1	15.5 micrograms per milliliter Standard Deviation 28.2	—

SECONDARY outcome

Timeframe: Up to cycle 10 day 1 (each cycle is 28 days)

Population: Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

Outcome measures

Measure	Arm B (Sequential PCV13 and Lenalidomide) n=25 Participants Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm A (Concurrent PCV13 and Lenalidomide) n=24 Participants Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Antibody Titre Levels for Serotype 33F Cycle 10 day 1	2.3 micrograms per milliliter Standard Deviation 3.2	—
Antibody Titre Levels for Serotype 33F Cycle 6 day 1	—	2.1 micrograms per milliliter Standard Deviation 2.2
Antibody Titre Levels for Serotype 33F Cycle 1 day 1	2.2 micrograms per milliliter Standard Deviation 2.7	2.1 micrograms per milliliter Standard Deviation 2.6
Antibody Titre Levels for Serotype 33F Cycle 3 day 1	2.6 micrograms per milliliter Standard Deviation 3.6	2.1 micrograms per milliliter Standard Deviation 2.6
Antibody Titre Levels for Serotype 33F Cycle 4 day 1	2.7 micrograms per milliliter Standard Deviation 3.8	—
Antibody Titre Levels for Serotype 33F Cycle 5 day 1	—	2.7 micrograms per milliliter Standard Deviation 3.2

Adverse Events

Arm A (Concurrent PCV13 and Lenalidomide)

Serious events: 12 serious events

Other events: 24 other events

Deaths: 0 deaths

Arm B (Sequential PCV13 and Lenalidomide)

Serious events: 13 serious events

Other events: 25 other events

Deaths: 1 deaths

Serious adverse events

Measure	Arm A (Concurrent PCV13 and Lenalidomide) n=24 participants at risk Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm B (Sequential PCV13 and Lenalidomide) n=25 participants at risk Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Cardiac disorders Atrial fibrillation	0.00% 0/24 • Up to 4 years	4.0% 1/25 • Number of events 3 • Up to 4 years
Cardiac disorders Chest pain- cardiac	0.00% 0/24 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Cardiac disorders Myocardial infarction	0.00% 0/24 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Gastrointestinal disorders Abdominal Pain	0.00% 0/24 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Gastrointestinal disorders Diarrhea	4.2% 1/24 • Number of events 1 • Up to 4 years	0.00% 0/25 • Up to 4 years
Gastrointestinal disorders Pancreatitis	4.2% 1/24 • Number of events 1 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
General disorders Fever	4.2% 1/24 • Number of events 1 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Hepatobiliary disorders Cholecystitis	4.2% 1/24 • Number of events 1 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Hepatobiliary disorders Gallbladder pain	4.2% 1/24 • Number of events 1 • Up to 4 years	0.00% 0/25 • Up to 4 years
Infections and infestations Appendicitis	0.00% 0/24 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Infections and infestations Lung infection	12.5% 3/24 • Number of events 3 • Up to 4 years	0.00% 0/25 • Up to 4 years
Infections and infestations Meningitis	0.00% 0/24 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Infections and infestations Urinary tract infection	4.2% 1/24 • Number of events 1 • Up to 4 years	0.00% 0/25 • Up to 4 years
Injury, poisoning and procedural complications Fall	4.2% 1/24 • Number of events 1 • Up to 4 years	0.00% 0/25 • Up to 4 years
Investigations Alanine Aminotransferase increased	0.00% 0/24 • Up to 4 years	8.0% 2/25 • Number of events 3 • Up to 4 years
Investigations Aspartate aminotransferase increased	0.00% 0/24 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Investigations Creatinine Increased	4.2% 1/24 • Number of events 1 • Up to 4 years	0.00% 0/25 • Up to 4 years
Investigations Lipase Increased	4.2% 1/24 • Number of events 1 • Up to 4 years	0.00% 0/25 • Up to 4 years
Investigations Neutrophil count decreased	8.3% 2/24 • Number of events 2 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Metabolism and nutrition disorders Dehydration	8.3% 2/24 • Number of events 2 • Up to 4 years	0.00% 0/25 • Up to 4 years
Metabolism and nutrition disorders Hypokalemia	4.2% 1/24 • Number of events 1 • Up to 4 years	0.00% 0/25 • Up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified, other	0.00% 0/24 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Nervous system disorders Syncope	4.2% 1/24 • Number of events 2 • Up to 4 years	0.00% 0/25 • Up to 4 years
Psychiatric disorders Confusion	0.00% 0/24 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Reproductive system and breast disorders Prostatic obstruction	4.2% 1/24 • Number of events 1 • Up to 4 years	0.00% 0/25 • Up to 4 years
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/24 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Skin and subcutaneous tissue disorders Rash Maculo-papular	8.3% 2/24 • Number of events 2 • Up to 4 years	0.00% 0/25 • Up to 4 years
Vascular disorders Hypertension	4.2% 1/24 • Number of events 1 • Up to 4 years	0.00% 0/25 • Up to 4 years

Other adverse events

Measure	Arm A (Concurrent PCV13 and Lenalidomide) n=24 participants at risk Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)	Arm B (Sequential PCV13 and Lenalidomide) n=25 participants at risk Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially)
Investigations Platelet count decreased	75.0% 18/24 • Number of events 67 • Up to 4 years	76.0% 19/25 • Number of events 66 • Up to 4 years
Investigations Weight gain	8.3% 2/24 • Number of events 2 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Investigations Weight loss	20.8% 5/24 • Number of events 7 • Up to 4 years	32.0% 8/25 • Number of events 13 • Up to 4 years
Investigations White blood cell decreased	50.0% 12/24 • Number of events 57 • Up to 4 years	36.0% 9/25 • Number of events 28 • Up to 4 years
Metabolism and nutrition disorders Anorexia	4.2% 1/24 • Number of events 1 • Up to 4 years	8.0% 2/25 • Number of events 3 • Up to 4 years
Metabolism and nutrition disorders Dehydration	8.3% 2/24 • Number of events 2 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Metabolism and nutrition disorders Hypercalcemia	12.5% 3/24 • Number of events 4 • Up to 4 years	24.0% 6/25 • Number of events 7 • Up to 4 years
Metabolism and nutrition disorders Hyperglycemia	100.0% 24/24 • Number of events 94 • Up to 4 years	96.0% 24/25 • Number of events 117 • Up to 4 years
Metabolism and nutrition disorders Hyperkalemia	8.3% 2/24 • Number of events 2 • Up to 4 years	16.0% 4/25 • Number of events 6 • Up to 4 years
Metabolism and nutrition disorders Hypernatremia	4.2% 1/24 • Number of events 1 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Metabolism and nutrition disorders Hyperuricemia	29.2% 7/24 • Number of events 14 • Up to 4 years	40.0% 10/25 • Number of events 37 • Up to 4 years
Metabolism and nutrition disorders Hypoalbuminemia	8.3% 2/24 • Number of events 3 • Up to 4 years	24.0% 6/25 • Number of events 12 • Up to 4 years
Metabolism and nutrition disorders Hypocalcemia	29.2% 7/24 • Number of events 22 • Up to 4 years	36.0% 9/25 • Number of events 18 • Up to 4 years
Metabolism and nutrition disorders Hypoglycemia	20.8% 5/24 • Number of events 7 • Up to 4 years	36.0% 9/25 • Number of events 18 • Up to 4 years
Metabolism and nutrition disorders Hypokalemia	37.5% 9/24 • Number of events 27 • Up to 4 years	40.0% 10/25 • Number of events 22 • Up to 4 years
Metabolism and nutrition disorders Hypomagnesemia	8.3% 2/24 • Number of events 2 • Up to 4 years	4.0% 1/25 • Number of events 3 • Up to 4 years
Metabolism and nutrition disorders Hyponatremia	16.7% 4/24 • Number of events 8 • Up to 4 years	12.0% 3/25 • Number of events 11 • Up to 4 years
Metabolism and nutrition disorders Hypophosphatemia	16.7% 4/24 • Number of events 15 • Up to 4 years	52.0% 13/25 • Number of events 58 • Up to 4 years
Metabolism and nutrition disorders Metabolism and nutrition disorders, other	0.00% 0/24 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Musculoskeletal and connective tissue disorders Arthralgia	20.8% 5/24 • Number of events 7 • Up to 4 years	24.0% 6/25 • Number of events 10 • Up to 4 years
Musculoskeletal and connective tissue disorders Arthritis	4.2% 1/24 • Number of events 1 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Musculoskeletal and connective tissue disorders Back pain	33.3% 8/24 • Number of events 10 • Up to 4 years	24.0% 6/25 • Number of events 7 • Up to 4 years
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder, other	16.7% 4/24 • Number of events 4 • Up to 4 years	12.0% 3/25 • Number of events 3 • Up to 4 years
Musculoskeletal and connective tissue disorders Myalgia	25.0% 6/24 • Number of events 9 • Up to 4 years	44.0% 11/25 • Number of events 14 • Up to 4 years
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 4/24 • Number of events 4 • Up to 4 years	16.0% 4/25 • Number of events 8 • Up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified, other	16.7% 4/24 • Number of events 6 • Up to 4 years	28.0% 7/25 • Number of events 9 • Up to 4 years
Nervous system disorders Dizziness	20.8% 5/24 • Number of events 7 • Up to 4 years	32.0% 8/25 • Number of events 10 • Up to 4 years
Nervous system disorders Dysesthesia	29.2% 7/24 • Number of events 11 • Up to 4 years	28.0% 7/25 • Number of events 9 • Up to 4 years
Nervous system disorders Dysgeusia	12.5% 3/24 • Number of events 3 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Nervous system disorders Headache	54.2% 13/24 • Number of events 19 • Up to 4 years	64.0% 16/25 • Number of events 29 • Up to 4 years
Nervous system disorders Paresthesia	20.8% 5/24 • Number of events 5 • Up to 4 years	20.0% 5/25 • Number of events 5 • Up to 4 years
Nervous system disorders Presyncope	4.2% 1/24 • Number of events 3 • Up to 4 years	8.0% 2/25 • Number of events 3 • Up to 4 years
Nervous system disorders Sinus pain	0.00% 0/24 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Psychiatric disorders Anxiety	0.00% 0/24 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Psychiatric disorders Confusion	8.3% 2/24 • Number of events 2 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Psychiatric disorders Depression	0.00% 0/24 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Psychiatric disorders Insomnia	16.7% 4/24 • Number of events 5 • Up to 4 years	16.0% 4/25 • Number of events 5 • Up to 4 years
Renal and urinary disorders Chronic kidney disease	20.8% 5/24 • Number of events 6 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Renal and urinary disorders Hematuria	0.00% 0/24 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Renal and urinary disorders Renal calculi	0.00% 0/24 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	41.7% 10/24 • Number of events 13 • Up to 4 years	36.0% 9/25 • Number of events 10 • Up to 4 years
Respiratory, thoracic and mediastinal disorders Cough	37.5% 9/24 • Number of events 14 • Up to 4 years	88.0% 22/25 • Number of events 27 • Up to 4 years
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 6/24 • Number of events 9 • Up to 4 years	44.0% 11/25 • Number of events 15 • Up to 4 years
Respiratory, thoracic and mediastinal disorders Epistaxis	8.3% 2/24 • Number of events 2 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Respiratory, thoracic and mediastinal disorders Hoarseness	4.2% 1/24 • Number of events 1 • Up to 4 years	12.0% 3/25 • Number of events 3 • Up to 4 years
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	4.2% 1/24 • Number of events 1 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Respiratory, thoracic and mediastinal disorders Nasal Congestion	20.8% 5/24 • Number of events 7 • Up to 4 years	20.0% 5/25 • Number of events 5 • Up to 4 years
Respiratory, thoracic and mediastinal disorders Postnasal drip	4.2% 1/24 • Number of events 1 • Up to 4 years	32.0% 8/25 • Number of events 12 • Up to 4 years
Respiratory, thoracic and mediastinal disorders Productive cough	20.8% 5/24 • Number of events 6 • Up to 4 years	36.0% 9/25 • Number of events 10 • Up to 4 years
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders, other	4.2% 1/24 • Number of events 1 • Up to 4 years	20.0% 5/25 • Number of events 6 • Up to 4 years
Respiratory, thoracic and mediastinal disorders Sore throat	37.5% 9/24 • Number of events 11 • Up to 4 years	56.0% 14/25 • Number of events 20 • Up to 4 years
Skin and subcutaneous tissue disorders Hyperhidrosis	4.2% 1/24 • Number of events 1 • Up to 4 years	16.0% 4/25 • Number of events 5 • Up to 4 years
Skin and subcutaneous tissue disorders Pruritus	12.5% 3/24 • Number of events 3 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Skin and subcutaneous tissue disorders Rash acneiform	16.7% 4/24 • Number of events 6 • Up to 4 years	0.00% 0/25 • Up to 4 years
Skin and subcutaneous tissue disorders Rash maculo-papular	66.7% 16/24 • Number of events 25 • Up to 4 years	36.0% 9/25 • Number of events 19 • Up to 4 years
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders, other	62.5% 15/24 • Number of events 40 • Up to 4 years	64.0% 16/25 • Number of events 32 • Up to 4 years
Vascular disorders Flushing	8.3% 2/24 • Number of events 2 • Up to 4 years	4.0% 1/25 • Number of events 2 • Up to 4 years
Vascular disorders Hypertension	95.8% 23/24 • Number of events 79 • Up to 4 years	100.0% 25/25 • Number of events 90 • Up to 4 years
General disorders Non-cardiac chest pain	12.5% 3/24 • Number of events 3 • Up to 4 years	8.0% 2/25 • Number of events 3 • Up to 4 years
General disorders Pain	37.5% 9/24 • Number of events 9 • Up to 4 years	28.0% 7/25 • Number of events 8 • Up to 4 years
Hepatobiliary disorders Gallbladder pain	8.3% 2/24 • Number of events 2 • Up to 4 years	0.00% 0/25 • Up to 4 years
Infections and infestations Bronchial infection	4.2% 1/24 • Number of events 1 • Up to 4 years	12.0% 3/25 • Number of events 4 • Up to 4 years
Infections and infestations Infections and infestations, other	12.5% 3/24 • Number of events 4 • Up to 4 years	20.0% 5/25 • Number of events 5 • Up to 4 years
Infections and infestations Lung infection	25.0% 6/24 • Number of events 6 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Infections and infestations Nail infection	8.3% 2/24 • Number of events 2 • Up to 4 years	8.0% 2/25 • Number of events 3 • Up to 4 years
Infections and infestations Papulopustular rash	4.2% 1/24 • Number of events 1 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Infections and infestations Prostate infection	0.00% 0/24 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Infections and infestations Sinusitis	25.0% 6/24 • Number of events 10 • Up to 4 years	20.0% 5/25 • Number of events 9 • Up to 4 years
Infections and infestations Skin infection	25.0% 6/24 • Number of events 7 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Infections and infestations Upper respiratory infection	54.2% 13/24 • Number of events 23 • Up to 4 years	60.0% 15/25 • Number of events 21 • Up to 4 years
Infections and infestations Urinary tract infection	12.5% 3/24 • Number of events 4 • Up to 4 years	12.0% 3/25 • Number of events 4 • Up to 4 years
Infections and infestations Vaginal infection	8.3% 2/24 • Number of events 3 • Up to 4 years	0.00% 0/25 • Up to 4 years
Injury, poisoning and procedural complications Bruising	16.7% 4/24 • Number of events 4 • Up to 4 years	36.0% 9/25 • Number of events 14 • Up to 4 years
Injury, poisoning and procedural complications Fall	8.3% 2/24 • Number of events 2 • Up to 4 years	28.0% 7/25 • Number of events 8 • Up to 4 years
Injury, poisoning and procedural complications Injury, poisoning and procedural complications, other	8.3% 2/24 • Number of events 2 • Up to 4 years	0.00% 0/25 • Up to 4 years
Investigations Alanine aminotransferase increased	41.7% 10/24 • Number of events 28 • Up to 4 years	60.0% 15/25 • Number of events 31 • Up to 4 years
Investigations Alkaline Phosphatase Increased	16.7% 4/24 • Number of events 10 • Up to 4 years	20.0% 5/25 • Number of events 7 • Up to 4 years
Investigations Aspartate Aminotransferase Increased	41.7% 10/24 • Number of events 28 • Up to 4 years	52.0% 13/25 • Number of events 24 • Up to 4 years
Investigations Blood bilirubin increased	20.8% 5/24 • Number of events 25 • Up to 4 years	28.0% 7/25 • Number of events 37 • Up to 4 years
Investigations Creatinine increased	33.3% 8/24 • Number of events 28 • Up to 4 years	20.0% 5/25 • Number of events 26 • Up to 4 years
Investigations Hemoglobin increased	0.00% 0/24 • Up to 4 years	8.0% 2/25 • Number of events 3 • Up to 4 years
Investigations Lymphocyte count decreased	37.5% 9/24 • Number of events 25 • Up to 4 years	28.0% 7/25 • Number of events 21 • Up to 4 years
Investigations Lymphocyte count increased	54.2% 13/24 • Number of events 25 • Up to 4 years	76.0% 19/25 • Number of events 35 • Up to 4 years
Investigations Neutrophil count decreased	87.5% 21/24 • Number of events 117 • Up to 4 years	96.0% 24/25 • Number of events 98 • Up to 4 years
Gastrointestinal disorders Nausea	20.8% 5/24 • Number of events 10 • Up to 4 years	36.0% 9/25 • Number of events 16 • Up to 4 years
Gastrointestinal disorders Oral pain	12.5% 3/24 • Number of events 4 • Up to 4 years	20.0% 5/25 • Number of events 5 • Up to 4 years
Gastrointestinal disorders Toothache	4.2% 1/24 • Number of events 2 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Gastrointestinal disorders Vomiting	8.3% 2/24 • Number of events 2 • Up to 4 years	28.0% 7/25 • Number of events 8 • Up to 4 years
General disorders Chills	8.3% 2/24 • Number of events 2 • Up to 4 years	0.00% 0/25 • Up to 4 years
General disorders Edema limbs	12.5% 3/24 • Number of events 3 • Up to 4 years	12.0% 3/25 • Number of events 4 • Up to 4 years
General disorders Fatigue	41.7% 10/24 • Number of events 11 • Up to 4 years	76.0% 19/25 • Number of events 21 • Up to 4 years
General disorders Fever	20.8% 5/24 • Number of events 5 • Up to 4 years	28.0% 7/25 • Number of events 7 • Up to 4 years
General disorders Flu like symptoms	16.7% 4/24 • Number of events 4 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
General disorders Localized edema	25.0% 6/24 • Number of events 7 • Up to 4 years	20.0% 5/25 • Number of events 9 • Up to 4 years
Gastrointestinal disorders Constipation	25.0% 6/24 • Number of events 14 • Up to 4 years	44.0% 11/25 • Number of events 16 • Up to 4 years
Gastrointestinal disorders Dental caries	0.00% 0/24 • Up to 4 years	8.0% 2/25 • Number of events 4 • Up to 4 years
Gastrointestinal disorders Diarrhea	70.8% 17/24 • Number of events 41 • Up to 4 years	84.0% 21/25 • Number of events 63 • Up to 4 years
Gastrointestinal disorders Dyspepsia	8.3% 2/24 • Number of events 2 • Up to 4 years	12.0% 3/25 • Number of events 7 • Up to 4 years
Gastrointestinal disorders Flatulence	12.5% 3/24 • Number of events 3 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Gastrointestinal disorders Gastroesophageal reflux disease	16.7% 4/24 • Number of events 5 • Up to 4 years	8.0% 2/25 • Number of events 3 • Up to 4 years
Gastrointestinal disorders Gastrointestinal disorders, other	16.7% 4/24 • Number of events 4 • Up to 4 years	12.0% 3/25 • Number of events 5 • Up to 4 years
Gastrointestinal disorders Mucositis oral	0.00% 0/24 • Up to 4 years	20.0% 5/25 • Number of events 6 • Up to 4 years
Blood and lymphatic system disorders Anemia	58.3% 14/24 • Number of events 46 • Up to 4 years	60.0% 15/25 • Number of events 38 • Up to 4 years
Blood and lymphatic system disorders Leukocytosis	8.3% 2/24 • Number of events 3 • Up to 4 years	20.0% 5/25 • Number of events 9 • Up to 4 years
Blood and lymphatic system disorders Lymph node pain	25.0% 6/24 • Number of events 7 • Up to 4 years	32.0% 8/25 • Number of events 10 • Up to 4 years
Cardiac disorders Cardiac disorders- other	8.3% 2/24 • Number of events 2 • Up to 4 years	4.0% 1/25 • Number of events 2 • Up to 4 years
Cardiac disorders Palpitations	0.00% 0/24 • Up to 4 years	12.0% 3/25 • Number of events 3 • Up to 4 years
Cardiac disorders Sinus bradycardia	37.5% 9/24 • Number of events 18 • Up to 4 years	28.0% 7/25 • Number of events 21 • Up to 4 years
Cardiac disorders Sinus Tachycardia	8.3% 2/24 • Number of events 2 • Up to 4 years	4.0% 1/25 • Number of events 2 • Up to 4 years
Ear and labyrinth disorders Ear and labyrinth disorders, other	4.2% 1/24 • Number of events 1 • Up to 4 years	12.0% 3/25 • Number of events 3 • Up to 4 years
Ear and labyrinth disorders Ear Pain	4.2% 1/24 • Number of events 1 • Up to 4 years	16.0% 4/25 • Number of events 4 • Up to 4 years
Ear and labyrinth disorders Tinnitus	4.2% 1/24 • Number of events 1 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Ear and labyrinth disorders Vertigo	4.2% 1/24 • Number of events 1 • Up to 4 years	8.0% 2/25 • Number of events 2 • Up to 4 years
Eye disorders Dry eye	8.3% 2/24 • Number of events 2 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Eye disorders Eye disorders, other	4.2% 1/24 • Number of events 1 • Up to 4 years	16.0% 4/25 • Number of events 4 • Up to 4 years
Eye disorders Floaters	8.3% 2/24 • Number of events 2 • Up to 4 years	4.0% 1/25 • Number of events 1 • Up to 4 years
Gastrointestinal disorders Abdominal pain	12.5% 3/24 • Number of events 3 • Up to 4 years	24.0% 6/25 • Number of events 10 • Up to 4 years
Gastrointestinal disorders Bloating	4.2% 1/24 • Number of events 1 • Up to 4 years	16.0% 4/25 • Number of events 7 • Up to 4 years

Additional Information

Dr. Kerry Rogers

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-3873

Email: Kerry.Rogers@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60