Daratumumab After Stem Cell Transplant in Treating Patients With Multiple Myeloma

NCT03346135 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 18560NCI-2017-02087
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

This phase II trial studies how well daratumumab after a stem cell transplant works in treating patients with multiple myeloma. Monoclonal antibodies, such as daratumumab, may kill cancer cells that are left after chemotherapy.

Conditions

Plasma Cell Myeloma; Secondary Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Will be estimated using the product-limit method of Kaplan-Meier.

  From date of first dose of study drug to first documented date of disease relapse, progression, or death (from any cause), whichever occurs first, assessed for up to 18 months after last dose of study drug

Secondary Outcomes (7)

• Minimal residual disease (MRD) defined as if a positive result is obtained using the Adaptive MRD testing

  Up to 30 days after last dose of study drug

• Incidence of adverse events graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0

  Up to 30 days after last dose of study drug

• Overall response rate (stringent complete response [sCR]/complete response [CR], very good partial response [VGPR]) based on the International Myeloma Working Group (IMWG) Uniform Response Criteria

  At 1 year

• Response duration

  From the date of first documented response (sCR/CR/VGPR) to documented disease relapse, progression, or death, whichever occurs first, assessed up to 18 months after last dose of study drug

• Depth of response

  Up to 18 months after last dose of study drug

Study Arms (1)

Treatment (ASCT, melphalan, daratumumab)

EXPERIMENTAL

Patients undergo standard of care ASCT with a conditioning regimen of melphalan. Beginning 60-120 days after ASCT, patients receive daratumumab IV every week for 8 weeks, every 2 weeks for 16 weeks, and then every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

Procedure: Autologous Hematopoietic Stem Cell Transplantation; Biological: Daratumumab; Other: Laboratory Biomarker Analysis; Drug: Melphalan

Interventions

Melphalan DRUG

Undergo standard of care ASCT with a conditioning regimen of melphalan

Also known as: Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine mustard, L-sarcolysin, L-Sarcolysin Phenylalanine mustard, L-Sarcolysine, Melphalanum, Phenylalanine Mustard, Phenylalanine Nitrogen Mustard, Sarcoclorin, Sarkolysin, WR-19813

Treatment (ASCT, melphalan, daratumumab)

Autologous Hematopoietic Stem Cell Transplantation PROCEDURE

Undergo standard of care ASCT with a conditioning regimen of melphalan

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

Treatment (ASCT, melphalan, daratumumab)

Daratumumab BIOLOGICAL

Given IV

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

Treatment (ASCT, melphalan, daratumumab)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (ASCT, melphalan, daratumumab)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must have the ability to understand and the willingness to sign a written informed consent
• Histologically confirmed diagnosis of multiple myeloma; (patients with multiple myeloma with secondary amyloidosis are eligible)
• Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-13 months of the first dose of initial therapy
• Eastern Cooperative Oncology Group (ECOG) =\< 2
• Patients with planned standard of care ASCT using melphalan 200 mg/m\^2; dose modifications in accordance with creatinine clearance levels are allowed per physician judgment
• Adequate organ function for high dose chemotherapy and autologous stem cell transplant (as per institution standard operating procedure \[SOP\])
• Adequate cell dose \> 2.5 x 10\^6 CD34+ cells/kg
• Absolute neutrophil count (ANC) \>= 1000/mm\^3
• Platelet count \>= 75,000/mm\^3; platelet transfusions to help patients meet eligibility criteria are not allowed within 7 days before study enrollment
• Total bilirubin =\< 1.5 x the upper limit of normal (ULN)
• Aspartate aminotransferase (AST) =\< 3 x ULN
• Alanine aminotransferase (ALT) =\< 3 x ULN
• Calculated creatinine clearance \>= 30 mL/min
• Woman of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected, or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods; condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization; true abstinence (when this is in line with the preferred and usual lifestyle of the subject) during and after the study (6 months after the last dose of daratumumab for women)
• A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug

You may not qualify if:

• Prior disease progression with daratumumab or other anti-CD38 antibody
• History of organ or previous autologous/allogeneic stem cell transplantation
• Any condition medical or psychosocial that in the opinion of the investigator would hinder compliance
• Female patients who are lactating or have a positive pregnancy test during the screening period
• History of plasma cell leukemia or central nervous system (CNS) involvement
• Major surgery within 14 days prior to start of study treatment
• Infection requiring systemic antibiotic therapy within 14 days prior to the start of study treatment
• Subject is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment; Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes) is acceptable
• Vaccination with live attenuated vaccines within 4 weeks of first study agent administration
• Subject is currently using or has used immunosuppressive medication within 14 days prior to the first dose of study treatment; the following are exceptions:
• Intranasal, topical, inhaled, or local steroid injections (e.g., intra-articular injection)
• Chronic systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
• Steroids as premedication for hypersensitivity reaction (e.g., infusion-related reactions, computed tomography \[CT\] scan premedication)
• Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloidosis
• Subjects with uncontrolled, systematic infection should be excluded

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Sarah Cannon Cancer Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Stem Cell Transplantation; daratumumab; Melphalan

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; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Amrita Y Krishnan

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

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: November 15, 2017
• First Posted: November 17, 2017
• Study Start: July 17, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (2)