Daratumumab in Treating Transplant-Eligible Patients With Multiple Myeloma

NCT03477539 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: MC1785NCI-2018-0033217-004126
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well daratumumab works in treating transplant-eligible patients with multiple myeloma. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.

Conditions

Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

• Rate of Minimal Residual Disease (MRD) Negative Response After Autologous Stem Cell Transplantation (ASCT)

  MRD negative response after ASCT is defined as achievement of MRD negative status in the bone marrow by flow cytometry (multiparameter flow cytometry \[MPF\]) at the day 100 post ASCT visit. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. 95 percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

  100 days

Secondary Outcomes (6)

• The Rate of MRD Negative Response After Pre-stem Cell Transplant (SCT) Consolidation With Daratumumab

  3 years

• Rate of MRD Negative Response After 1 Year (12 Courses) of Daratumumab and Lenalidomide Maintenance

  1 year

• Progression-free Survival

  3 years

• Overall Survival

  3 years

• Overall Response Rate

  100 days

Other Outcomes (4)

• MRD Assessment in Blood and Bone Marrow

  Up to cycle 18/16 months of treatment

• MRD Assessed Using Flow Cytometry (MPF) and Next Generation Sequencing (NGS)

  Up to cycle 18/16 months of treatment

• Immune Repertoire Profiling

  Up to cycle 18/16 months of treatment

Study Arms (1)

Treatment (daratumumab, ASCT, lenalidomide)

EXPERIMENTAL

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.

Procedure: Autologous Hematopoietic Stem Cell Transplantation; Biological: Daratumumab; Drug: Lenalidomide

Interventions

Autologous Hematopoietic Stem Cell Transplantation PROCEDURE

Undergo ASCT

Also known as: AHSCT, Autologous, Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell Transplant, Autologous Stem Cell Transplantation, Stem Cell Transplantation, Autologous

Treatment (daratumumab, ASCT, lenalidomide)

Daratumumab BIOLOGICAL

Given IV

Also known as: Anti-CD38 Monoclonal Antibody, Darzalex, HuMax-CD38, JNJ-54767414

Treatment (daratumumab, ASCT, lenalidomide)

Lenalidomide DRUG

Given PO

Also known as: CC-5013, CC5013, CDC 501, Revlimid

Treatment (daratumumab, ASCT, lenalidomide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Considered transplant eligible
• Pathologically confirmed diagnosis of multiple myeloma who are transplant eligible and have received any prior induction therapy (with or without maintenance)
• Measurable MRD in bone marrow within 28 days prior to registration (MPF method)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 at registration
• Absolute neutrophil count (ANC) \>= 1,000 cell/mm\^3 without growth factor support, obtained =\< 14 days prior to registration
• Platelets \>= 50,000 cells/mm\^3 for patients who have bone marrow plasmacytosis \< 50% or \>= 30,000 cells/mm\^3 for patients who have bone marrow plasmacytosis of \>= 50%, obtained =\< 14 days prior to registration
• Calculated or measured creatinine clearance \>= 30 ml/min, obtained =\< 14 days prior to registration
• Total bilirubin =\< 1.5 x upper limit of normal (ULN) unless due to Gilbert's syndrome, in which case the direct bilirubin must be =\< 1.5 X ULN, obtained =\< 14 days prior to registration
• Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) =\< 3 x ULN, obtained =\< 14 days prior to registration
• Prothrombin time (PT)/international normalized ratio (INR) =\< 1.5 X ULN, obtained =\< 14 days prior to registration
• Negative urine or serum pregnancy test for women of childbearing potential
• NOTE: females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program
• Provide informed written consent
• Measurable disease of multiple myeloma at the time specified by one of the following:
• If no relapse prior to transplant, values obtained at the time of diagnosis

You may not qualify if:

• Any previous ASCT for multiple myeloma (MM) (NOTE: Patient may have had prior stem cell collection before registration on the study)
• Any prior therapy with daratumumab
• Non-secretory MM or known amyloid light-chain (AL) amyloidosis
• Clinically significant active infection requiring intravenous antibiotics (=\< 14 days prior to registration)
• \>= grade 3 neuropathy and/or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Other prior malignancy
• Exceptions:
• Adequately treated basal cell or squamous cell skin cancer
• Any in situ cancer
• Adequately treated stage I or II cancer from which the patient is currently in complete remission, or
• Any other cancer from which the patient has been disease free for at least 3 years
• Concurrent therapy considered investigational
• NOTE: patients must not be planning to receive any radiation therapy (except localized radiation for palliative care that must be completed prior to starting cycle 1, day 1)
• Pregnant women
• Nursing women (lactating females are eligible provided that they agree not to breast feed while taking lenalidomide)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Stem Cell Transplantation; daratumumab; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Sikander Ailawadhi
• Organization: Mayo Clinic

ailawadhi.sikander@mayo.edu

904-953-0450

Study Officials

• Sikander Ailawadhi, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 26, 2018
• Study Start: April 9, 2018
• Primary Completion: May 11, 2022
• Study Completion: March 24, 2025
• Last Updated: May 5, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-01

Locations

US (1)