What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly those involving monoclonal antibodies like daratumumab, elotuzumab, and isatuximab, are associated with several side effects. Daratumumab can cause neutropenia, lymphocytopenia, and higher rates of infections, including pneumonia and viral reactivations such as herpes zoster and CMV. Elotuzumab is linked to neutropenia, lymphocytopenia, and increased herpes zoster episodes. Isatuximab also shows higher rates of neutropenia and infections. Combination therapies with these agents often exacerbate these side effects, leading to higher incidences of severe infections and hematologic toxicities.

What prior FDA approvals exist?

Daratumumab, an anti-CD38 monoclonal antibody, has been approved by the FDA for the treatment of Multiple Myeloma, both as a monotherapy and in combination with other agents such as bortezomib, lenalidomide, and dexamethasone. Other similar treatments include isatuximab, another anti-CD38 monoclonal antibody, approved for use in combination with pomalidomide and dexamethasone. Elotuzumab, targeting SLAMF7, is approved in combination with lenalidomide and dexamethasone. These treatments work by inducing immune-mediated destruction of myeloma cells and have shown efficacy in various stages of Multiple Myeloma.

What other types of research exist?

Promising alternatives to Daratumumab for Multiple Myeloma patients include: <ol> <li>Isatuximab: Another CD38-targeting monoclonal antibody, often combined with pomalidomide and dexamethasone.</li> <li></li> </ol> Belantamab mafodotin: An antibody-drug conjugate targeting B-cell maturation antigen (BCMA). 3. Teclistamab: A bispecific antibody targeting BCMA and CD3. 4. Selinexor: An oral selective inhibitor of nuclear export, often combined with bortezomib and dexamethasone. 5. CAR T-cell therapies: Such as Idecabtagene Vicleucel, targeting BCMA.

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Monoclonal Antibodies

Daratumumab for Multiple Myeloma

Phase 2

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Confirmed diagnosis of intermediate or high-risk SMM

Must not have

Active multiple myeloma requiring treatment as defined by the study protocol

Primary systemic AL (immunoglobulin light chain) amyloidosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how often daratumumab should be given to patients with early-stage multiple myeloma at high risk of becoming active. The medication helps the immune system target and kill cancer cells. Daratumumab is a unique antibody approved for treating multiple myeloma.

Who is the study for?

This trial is for people who've been diagnosed with Smoldering Multiple Myeloma (SMM) within the last 5 years and are at intermediate or high risk. They should be relatively healthy, able to perform daily activities without significant assistance (ECOG score of 0 or 1). People can't join if they have other serious health issues, need treatment for active multiple myeloma, have had certain cancer treatments recently, or have a history of severe lung conditions.

What is being tested?

The study is testing three different schedules for administering Daratumumab to see which one works best for patients with SMM. Daratumumab is an antibody that targets specific cells in the body's immune system that are involved in the development of multiple myeloma.

What are the potential side effects?

Daratumumab may cause side effects such as infusion reactions (symptoms like fever and chills during administration), fatigue, nausea, back pain, cough and shortness of breath. It can also affect blood cell counts leading to increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My condition is diagnosed as intermediate or high-risk smoldering multiple myeloma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My multiple myeloma needs treatment.

Select...

I have been diagnosed with AL amyloidosis.

Select...

I have been diagnosed with COPD or severe asthma in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The percentage of participants who achieve a complete response (CR)

Secondary study objectives

The median time of progression free survival (PFS)

The percentage of participants who achieve a Complete Response (CR) or a Partial Response (PR)

Time to next treatment (TNT)

Side effects data

From 2020 Phase 1 & 2 trial • 22 Patients • NCT02841033

86%

Diarrhea

82%

Cough

82%

Lymphocyte count decreased

77%

Creatinine Increased

73%

Fatigue

73%

Hypertriglyceridemia

68%

Anemia

64%

Hypermagnesemia

64%

Myalgia

64%

Headache

59%

Cholesterol high

59%

Hyperuricemia

59%

Nausea

55%

Back pain

55%

Insomnia

50%

Hypoalbuminemia

50%

Dizziness

50%

Chronic kidney disease

50%

Upper respiratory infection

45%

Sore throat

45%

Edema limbs

45%

Alkaline phosphatase increased

45%

Cardiac troponin I increased

45%

CPK increased

45%

Platelet count decreased

45%

Pain in extremity

45%

Bruising

41%

Nasal congestion

41%

Dyspnea

36%

Abdominal pain

36%

Constipation

36%

Paresthesia

36%

Vomiting

36%

Rhinitis infective

36%

Aspartate aminotransferase increased (AST)

36%

Hypophosphatemia

36%

Metabolic and nutrition disorders - other, specify: iron deficiency

32%

Rhinorrhea

32%

Abdominal distention

32%

Eye disorders - other, specify: subconjunctival hemorrhage

32%

Fever

32%

Arthalgia

32%

Neck pain

32%

Anorexia

32%

Hyponatremia

32%

Rash maculopapular

27%

Post nasal drip

27%

Productive cough

27%

Total bilirubin increased

27%

White blood cell decreased

27%

Hyperkalemia

27%

Hoarseness

23%

Neutrophil count decreased

23%

Hypoglycemia

23%

Hematuria

23%

Urinary frequency

23%

Hypercalcemia

18%

Atrial fibrillation

18%

Chills

18%

Musculoskeletal and connective tissue disorder - other, specify: Restless legs

18%

Hyperglycemia

18%

Epistaxis

14%

Hyperthyroidism

14%

Blurred vision

14%

Acute kidney injury

14%

Heart failure

14%

Lung infection

14%

Ear pain

14%

Tinnitus

14%

Localized Edema

14%

Hypocalcemia

14%

Flank pain

14%

Peripheral sensory neuropathy

14%

Nocturia

14%

Allergic Rhinitis

14%

Endocrine disorder - other, specify: TSH elevated

14%

Gastroesophageal Reflux

14%

Oral pain

14%

Sinusitis

14%

Pruritus

14%

Rash acneiform

14%

Skin and Subcutaneous tissue disorders - other, specify: bug bite

14%

Skin and Subcutaneous tissue disorders - other, specify: Laceration

14%

Hypertension

Dysgeusia

Congestion

Conjunctivitis

Alopecia

Sepsis

Syncope

Palpitations

Hearing loss

Dry eye

Flu like symptoms

Fall

Investigations - other, specify: Lactate dehydrogenase elevated

Metabolic and nutrition disorders - other, specify: Type 2 diabetes mellitus

Neck stiffness

Proteinuria

Gastrointestinal disorder - other, specify: Tooth extraction

Gastrointestinal disorder - other, specify: inguinal hernia

Serum amylase increased

Weight gain

Dehydration

Metabolic and nutrition disorders - other, specify: increased appetite

Tremor

Anxiety

Depression

Dry Skin

Nail infection

Surgical procedure - other, specify: pre-cancerous areas removed

Periorbital edema

Cataract

Eye disorders - other, specify: obstructive tear duct

Eye disorders - other, specify: redness

Eye disorders - other, specify: scleral abrasian

Vaginal infection

Alanine aminotransferase increased (ALTT)

Wheezing

Hypothyroidism

Watering eyes

Bloating

Gastrointestinal hemorrhage - melena

Myocardial infarction (NSTEMI)

Renal and urinary disorders - other, UTI sepsis

Thromboembolic event

Upper gastrointestinal bleeding

Urinary tract infection

Urine output decreased

Lymph node pain

Chest pain - cardiac

Vertigo

Eye disorders - other, specify: cloudiness

Eye disorders - other, specify: Scotoma

Eye infection

Floaters

Anal hemorrhage

Dental caries

Dry mouth

Flatulence

Gait disturbance

Cystitis non-infective

Metabolic and nutrition disorders - other, specify: vitamin B12 deficiency

Arthritis

Generalized muscle weakness

Muscle weakness lower limb

Musculoskeletal and connective tissue disorder - other, specify: Dupuytren's contracture

Neoplasms - other, specify: basal cell carcinoma on sternum

Concentration impairment

Dysphagia

Memory impairment

Nervous system disorders - Other, specify: Autonomic Postural Hypotension

Irritability

Urinary incontinence

Urinary tract pain

Urinary urgency

Genital edema

Bronchospasm

Sleep apnea

Hypotension

CK increased

Colitis

Gastrointestinal disorder - other, specify: ulcer - Left lateral tongue

Gastrointestinal disorder - other, specify: viral gastroenteritis

Chest pain

Chest pain - non cardiac

Gastrointestinal disorder - other, specify: black stool

Gastrointestinal disorder - other, specify: broken tooth

Gastrointestinal disorder - other, specify: H. pylori

Immune system disorders - other, specify: lymphadenopathy

Laryngitis

Pharyngitis

Tooth infection

Weight loss

Hypokalemia

Hypomagnesemia

Agitation

Confusion (forgetfullness)

Mania

Hiccups

Hypoxia

Laryngeal inflammation

Photosensitivity

Rash

Skin & subcutaneous tissue disorders - other, specify: cercarial dermatitis/swimmer's itch

Skin and Subcutaneous tissue disorders - other, specify: Abrasion

Skin and Subcutaneous tissue disorders - other, specify: erythema

Skin and subcutaneous tissue disorders - other, specify: Skin sensitivity

Skin and Subcutaneous tissue disorders - other, specify: Wound

Skin induration

Surgical procedure - other, specify: Biopsy /wart removal

Surgical procedure - other, specify: biopsy, face, head, back

Surgical procedure - other, specify: shaved excision of dysplastic nevus

Arterial injury

Hot flashes

100%

80%

60%

40%

20%

Study treatment Arm

Daratumumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C (Short Intense)Experimental Treatment1 Intervention

Group II: Arm B (Intermediate)Experimental Treatment1 Intervention

Group III: Arm A (Long Intense)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

daratumumab

2017

Completed Phase 2

~180

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Myeloma treatments often involve monoclonal antibodies like Daratumumab, which target specific proteins on myeloma cells. Daratumumab binds to CD38, a protein highly expressed on myeloma cells, leading to immune-mediated destruction through mechanisms such as antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. This targeted approach helps to specifically eliminate myeloma cells while sparing normal cells, reducing side effects and improving patient outcomes. Other treatments, such as Elotuzumab and Isatuximab, also target surface proteins on myeloma cells to enhance immune response. These therapies are crucial as they offer more effective and less toxic options for managing Multiple Myeloma, improving survival rates and quality of life for patients.

Monoclonal Antibodies in Cancer Therapy.CD38 expression and complement inhibitors affect response and resistance to daratumumab therapy in myeloma.