Short Course Daratumumab in Patients With Multiple Myeloma

NCT03490344 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 18-048
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to test the safety of short course Daratumumab in combination with lenalidomide and to find out what effects, if any, short course Daratumumab in combination with lenalidomide has on people and their risk of multiple myeloma. The study is also designed to test the amount of remaining myeloma cells in your body after treatment with daratumumab which is known as minimal residual disease (MRD).

Conditions

Multiple Myeloma

Keywords

bony plasmacytoma; extramedullary plasmacytoma; Daratumumab; lenalidomide; Memorial Sloan Kettering Cancer Center; 18-048

Outcome Measures

Primary Outcomes (1)

• Number of Participants With MRD Negativity by the Completion of 6 Months of Daratumumab Therapy

  6 months

Study Arms (1)

Participants with Multiple Myeloma

EXPERIMENTAL

Participants with MM with very good partial response (VGPR) or better after induction therapy with/without consolidative HDT/ASCT and MRD positive by bone marrow flow cytometry and MM participants who were previously MRD negative after induction and consolidation and recently (within last 3 months) turned MRD positive by bone marrow flow cytometry will be enrolled.

Drug: Daratumumab; Drug: Lenalidomide

Interventions

Daratumumab DRUG

* Cycles 1 and 2: Daratumumab 16mg/kg weekly per cycle (28 days) as intravenous infusion (total duration: 8 weeks) * Cycles 3-6: Daratumumab 16mg/kg once every 2 weeks per cycle (28 days) as intravenous infusion (total duration: 16 weeks)

Participants with Multiple Myeloma

Lenalidomide DRUG

Lenalidomide maintenance therapy to be administered as standard treatment to all participants. This is administered as 5-15 mg daily 21-28/28 day cycle.

Participants with Multiple Myeloma

Eligibility Criteria

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

You may qualify if:

• Patients with a diagnosis of Multiple Myeloma who have achieved a VGPR or better (based on best response) after induction with or without consolidation therapy/ HDT ASCT
• MRD positive at screening by flow cytometry
• Additionally, patients who were previously MRD negative after induction therapy with/without consolidative HDT/ASCT and have turned MRD positive (by flow cytometry) based on bone marrow done at screening and do not have any evidence of progressive disease are eligible
• Patients must be on standard of care lenalidomide maintenance therapy for at least 6 months at the time of study enrollment
• Patient can be receiving bisphosphonate therapy per the treating oncologist's discretion
• Creatinine clearance ≥45 ml/min using the Cockcroft-Gault method, MDRD, or CKD-EPI formula. If the calculated CrCl based on Cockcroft-Gault method, MDRD, or CKD-EPI is \<45 mL/min, patient will have a 24 hr urine collection to measure CrCl.
• Age ≥18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Male or female patient who accepts and is able to use recognized effective contraception (oral contraceptives, IUCD, barrier method of contraception in conjunction with spermicidal jelly) throughout the study when relevant.
• Absolute neutrophil count (ANC) ≥1.0 x 10\^9/L, hemoglobin ≥8 g/dL, and platelet count ≥75 x 10\^9/L. No transfusion or growth factor support for one week prior to labs.
• Adequate hepatic function, with bilirubin \< 1.5 x the ULN, and AST and ALT \< 2.5 x ULN

You may not qualify if:

• Patients with a diagnosis of MM not achieving a VGPR or better to the most recent therapy.
• Patients with a diagnosis of MM who are MRD Negative by flow cytometry
• Patients must not have measurable disease at the time of enrollment. Measurable disease is defined as follows
• Serum monoclonal protein \> 0.5 gm/dL
• Urine monoclonal protein \> 200 mg/24 hours
• Involved serum free light chain \> 10 mg/dL
• Pregnant or lactating females
• Uncontrolled hypertension or diabetes
• Has significant cardiovascular disease with NYHA Class III or IV symptoms, or hypertrophic cardiomegaly, or restrictive cardiomegaly, or myocardial infarction within 3 months prior to enrollment, or unstable angina, or unstable arrhythmia
• Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance of study requirements
• Active infection requiring treatment within two weeks prior to first dose
• Contraindication to any concomitant medication, including antivirals, anticoagulation prophylaxis, tumor lysis prophylaxis, or hydration given prior to therapy
• Major surgery within 1 month prior to enrollment
• Previous therapy with daratumumab or other anti-CD38 monoclonal antibodies
• History of other malignancy (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma) except if the patient has been free of symptoms and without active therapy during at least 5 years

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (7)

Memoral Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memoral Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memoral Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Multiple Myeloma

Interventions

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)

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: Dr. Sham Mailankody, MBBS
• Organization: Memorial Sloan Kettering Cancer Center

mailanks@mskcc.org

646-608-3712

Study Officials

• Sham Mailankody, MBBS

  Memorial Sloan Kettering Cancer Center

  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 30, 2018
• First Posted: April 6, 2018
• Study Start: May 3, 2018
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: May 25, 2025
• Results First Posted: November 7, 2023

Record last verified: 2023-03

Locations

US (7)