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Monoclonal Antibodies

Daratumumab for Multiple Myeloma

Phase 2

Waitlist Available

Led By Sikander Ailawadhi

Research Sponsored by Mayo Clinic

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 (PS) 0, 1, or 2 at registration

Pathologically confirmed diagnosis of multiple myeloma who are transplant eligible and have received any prior induction therapy (with or without maintenance)

Must not have

Any prior therapy with daratumumab

Non-secretory MM or known amyloid light-chain (AL) amyloidosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year (12 cycles) of daratumumab and lenalidomide maintenance

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well daratumumab works in treating patients with multiple myeloma who are eligible for a transplant. Daratumumab is an antibody that may help to stop cancer cells from growing and spreading.

Who is the study for?

This trial is for transplant-eligible patients with multiple myeloma who have had prior therapy but not daratumumab. They must show measurable cancer markers, be in decent physical condition (ECOG 0-2), and have adequate organ function. Pregnant or breastfeeding women, those unwilling to use contraception, or individuals with certain medical conditions like severe infections, heart issues, or other cancers are excluded.

What is being tested?

The study is testing the effectiveness of daratumumab in treating multiple myeloma in patients eligible for a stem cell transplant. Daratumumab is an antibody that targets cancer cells to prevent their growth. The trial includes autologous hematopoietic stem cell transplantation and lenalidomide as part of the treatment process.

What are the potential side effects?

Daratumumab can cause side effects such as infusion reactions (symptoms similar to allergic reactions during administration), fatigue, nausea, bone marrow suppression leading to low blood counts which increases infection risk, and potential liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of my waking hours.

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I have multiple myeloma and am eligible for a transplant after receiving initial treatment.

Exclusion Criteria

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

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I have previously been treated with daratumumab.

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My condition is either non-secretory multiple myeloma or AL amyloidosis.

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I am of childbearing age and do not plan to use birth control.

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I have severe COPD or asthma with low lung function.

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I am HIV positive.

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I am not planning to receive any experimental treatments or radiation therapy, except for palliative care.

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I have been diagnosed with hepatitis B or C.

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My multiple myeloma has spread to the lining of my brain and spinal cord.

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I have severe nerve damage or POEMS syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year (12 cycles) of daratumumab and lenalidomide maintenance

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year (12 cycles) of daratumumab and lenalidomide maintenance

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year (12 cycles) of daratumumab and lenalidomide maintenance for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of minimal residual disease (MRD) negative response after autologous stem cell transplantation (ASCT)

Secondary study objectives

Incidence of adverse events

Overall response rate

Progression-free survival

+3 more

Other study objectives

Antibody-dependent cellular phagocytosis and antibody-dependent cell-mediated cytotoxicity

Immune repertoire profiling

MRD assessed using flow cytometry (MPF) and next generation sequencing (NGS)

+1 more

Side effects data

From 2022 Phase 3 trial • 665 Patients • NCT00567567

84%

58300-Neutrophil count decreased

70%

65800-Platelet count decreased

20%

43100-Hypokalemia

18%

44800-Infections and infestations - Other specify

18%

33300-Febrile neutropenia

17%

88500-White blood cell decreased

13%

13200-Anemia

55600-Mucositis oral

42700-Hypocalcemia

13500-Anorexia

11600-Alanine aminotransferase increased

41400-Hyperglycemia

15000-Aspartate aminotransferase increased

43300-Hyponatremia

73700-Sepsis

53700-Lymphocyte count decreased

25700-Diarrhea

65900-Pleural effusion

57600-Nausea

37500-GGT increased

41600-Hyperkalemia

10300-Abdominal pain

20500-Catheter related infection

59700-Oral pain

38900-Hearing impaired

43900-Hypoxia

17200-Blood and lymphatic system disorders - Other specify

14900-Ascites

75700-Small intestinal obstruction

87900-Vomiting

43600-Hypotension

34000-Fibrinogen decreased

23000-Confusion

42600-Hypoalbuminemia

45800-INR increased

69700-Rash maculo-papular

71500-Respiratory failure

73900-Serum amylase increased

26600-Duodenal obstruction

66300-Pneumonitis

58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify

56600-Myelitis

75600-Small intestinal mucositis

66800-Postoperative hemorrhage

43500-Hypophosphatemia

37300-Generalized muscle weakness

81200-Treatment related secondary malignancy

31200-Esophagitis

83100-Urinary tract infection

24100-Creatinine increased

11100-Acute kidney injury

62600-Pelvic pain

65300-Pharyngolaryngeal pain

31900-Eye disorders - Other specify

10900-Activated partial thromboplastin time prolonged

11800-Alkaline phosphatase increased

42500-Hyperuricemia

17400-Blood bilirubin increased

63100-Pericardial effusion

72700-Right ventricular dysfunction

37200-General disorders and administration site conditions - Other specify

40000-Hepatic failure

88200-Weight gain

41300-Hypercalcemia

54900-Metabolism and nutrition disorders - Other specify

71000-Renal and urinary disorders - Other specify

69000-Pulmonary hypertension

20100-Cardiac disorders - Other specify

22100-Colitis

44200-Ileal obstruction

81900-Typhlitis

33900-Fever

35500-Gallbladder pain

40600-Hepatobiliary disorders - Other specify

66500-Portal hypertension

12000-Allergic reaction

13100-Anaphylaxis

44700-Immune system disorders - Other specify

13400-Anorectal infection

25600-Device related infection

29500-Enterocolitis infectious

53100-Lung infection

62500-Pelvic infection

75200-Skin infection

82300-Upper respiratory infection

14500-Arterial injury

15300-Ataxia

38800-Headache

63900-Peripheral motor neuropathy

11300-Adult respiratory distress syndrome

29700-Epistaxis

78100-Stridor

68400-Pruritus

51700-Left ventricular systolic dysfunction

27800-Dyspnea

58100-Nervous system disorders - Other specify

29000-Encephalopathy

42100-Hypertension

24700-Dehydration

43200-Hypomagnesemia

31800-Extrapyramidal disorder

52600-Lipase increased

10700-Acidosis

100%

80%

60%

40%

20%

Study treatment Arm

Tandem HST (CEM), Randomly Assigned

Single HST (CEM)

Not Assigned

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (daratumumab, ASCT, lenalidomide)Experimental Treatment3 Interventions

CONSOLIDATION I: Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION II: Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. MAINTENANCE: Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~2240

Daratumumab

2014

Completed Phase 3

~2380