A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

• ClinicalTrials.gov Identifier: NCT03412565
• Recruitment Status: Active, not recruiting
• First Posted: January 26, 2018
• Results First Posted: January 12, 2022
• Last Update Posted: March 15, 2023
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Study Description

Brief Summary:

The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Drug: Daratumumab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Melphalan; Drug: Prednisone; Drug: Carfilzomib	Phase 2

Detailed Description:

The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 265 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens
• Actual Study Start Date: April 26, 2018
• Actual Primary Completion Date: August 12, 2020
• Estimated Study Completion Date: June 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd); Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.	Drug: Daratumumab; Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.; Drug: Bortezomib; Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.; Drug: Lenalidomide; Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.; Drug: Dexamethasone; Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.
Experimental: D + Bortezomib + Melphalan + Prednisone (D-VMP); Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.	Drug: Daratumumab; Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.; Drug: Bortezomib; Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.; Drug: Melphalan; Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.; Drug: Prednisone; Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.
Experimental: Daratumumab + Lenalidomide + Dexamethasone (D-Rd); Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or end of study.	Drug: Daratumumab; Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.; Drug: Lenalidomide; Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.; Drug: Dexamethasone; Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.
Experimental: Daratumumab + Carfilzomib + Dexamethasone (D-Kd); Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days) then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; Carfilzomib 20 mg/m^2 intravenously (IV) on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or IV weekly for Cycles 1-9 then on Days 1, 8, 15 of each cycle for Cycles 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.	Drug: Daratumumab; Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.; Drug: Dexamethasone; Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.; Drug: Carfilzomib; Carfilzomib will be administered as 20 mg/m^2 IV on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Kd cohort.

Outcome Measures

Primary Outcome Measures :

1. D-VMP, D-Rd, and D-Kd Cohorts: Overall Response Rate (ORR) [ Time Frame: Up to 2 years 3 months ]
   ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 milligrams (mg) per 24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.
2. D-VRd Cohort: Percentage of Participants With Very Good Partial Response (VGPR) or Better Response [ Time Frame: Up to 2 years and 3 months ]
   VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response [sCR]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg/24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and <5% PCs in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry.

Secondary Outcome Measures :

1. Maximum Observed Serum Concentration (Cmax) of Daratumumab [ Time Frame: D-VRd: Day 4 of Cycles 1 and 4 and post treatment at Week 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment at Week 8; D-Rd and D-Kd: Day 4 of Cycles 1 and 3 and post treatment at Week 8 ]
   Cmax was defined as maximum serum concentration observed following daratumumab administration. Each cycle for: D-VRd cohort is of 21 days, D-VMP cohort is of 42 days and D-Rd and D-Kd cohorts is of 28 days. Each cohort have a treatment period of 84 days.
2. Percentage of Participants With Infusion-Related Reactions (IRRs) [ Time Frame: Up to 2 years and 3 months ]
   Percentage of Participants with IRRs were reported. The administration-related systemic reactions are referred to as IRRs.
3. D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With VGPR or Better Response [ Time Frame: Up to 2 years and 3 months ]
   VGPR or better rate was defined as the percentage of participants who achieved VGPR or CR (including sCR) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and <5% PCs in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry.
4. D-VRd Cohort: Overall Response Rate (ORR) [ Time Frame: Up to 2 years and 3 months ]
   ORR was defined as the percentage of participants who achieved a PR or better, IMWG criteria, during the study or during follow up. IMWG criteria for PR >= 50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.
5. Percentage of Participants With CR or Better Response [ Time Frame: Up to 2 years and 3 months ]
   CR or better rate was defined as the percentage of participants with a CR or better response (that is, CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow; sCR: CR plus normal FLC ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
6. D-VMP, D-Rd and D-Kd Cohorts: Duration of Response (DOR) [ Time Frame: Up to 2 years and 3 months ]
   DOR was defined as the time from the date of initial documented response (PR or better response) to the date of first documented evidence of progressive disease (PD) or death due to PD. PD is defined as an increase of 25% from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >=0.5 gram per deciliter [g/dL] and >=200 mg/24 hours respectively); only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dL); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
7. Percentage of Participants With Anti-Daratumumab Antibodies [ Time Frame: Up to 10 months ]
   Percentage of participants with antibodies to daratumumab were reported.
8. Percentage of Participants With Anti-rHuPH20 Antibodies [ Time Frame: Up to 10 months ]
   Percentage of participants with antibodies to rHuPH20 were reported.
9. D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With Minimal Residual Disease (MRD) Negative Rate [ Time Frame: Up to 2 years and 3 months ]
   MRD negativity rate was defined as the percentage of participants who were considered MRD negative after MRD testing at any timepoint after the first dose by bone marrow aspirate. MRD negativity rate was assessed by next-generation sequencing at a threshold of <10^5.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria

• Measurable, secretory disease as defined by any of the following:

  1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or
  2. Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or
  3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio

• Meets one of the sets of the following criteria:

  1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma
  2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) and Daratumumab + Carfilzomib + Dexamethasone (D-Kd) regimen: relapsed or refractory disease
  3. D-Kd cohort: Participants must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2
• During the study, during dose interruptions, and for 3 months after receiving the last dose of any component of the study treatment, a female participant must agree not to donate eggs (ova, oocytes) and male participants of reproductive potential must not donate semen or sperm during the study, during dose interruptions, or for 3 months after the last dose of any study drug

Exclusion Criteria:

• History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
• Exhibits clinical signs of meningeal involvement of MM
• Either of the following: a) Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 percentage (%) of predicted normal b) Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification c) For D-Kd cohort: Known infiltrative pulmonary disease or known pulmonary hypertension
• Any of the following: a) Known to be seropositive for human immunodeficiency virus; b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [Anti-HBc] and/or antibodies to hepatitis B surface antigen [Anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are polymerase chain reaction (PCR) positive will be excluded
• Known to be seropositive for hepatitis C (Anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy
• For D-Kd cohort only: Transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) <40%; uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic >99 mmHg despite optimal treatment

Contacts and Locations

Locations

United States, Connecticut

Cancer Center of Central Connecticut - Southington

Southington, Connecticut, United States, 06489-3237

United States, Florida

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224

UF Health Cancer Center at Orlando Health

Orlando, Florida, United States, 32806

United States, Michigan

Karmonos Cancer Institute

Detroit, Michigan, United States, 48201

Providence Cancer Center

Southfield, Michigan, United States, 48075

United States, Montana

Billings Clinic

Billings, Montana, United States, 59101

United States, Nebraska

Nebraska Hematology and Oncology

Lincoln, Nebraska, United States, 68506

Southeast Nebraska Cancer Center

Lincoln, Nebraska, United States, 68510

Nebraska Cancer Specialists

Omaha, Nebraska, United States, 68130

United States, New Mexico

San Juan Oncology Associates

Farmington, New Mexico, United States, 87401

United States, New York

NYU Winthrop

Mineola, New York, United States, 11501

Mt. Sinai School of Medicine

New York, New York, United States, 10029

United States, North Carolina

Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27157

United States, South Dakota

Avera Medical Group - Oncology & Hematology

Sioux Falls, South Dakota, United States, 57105

United States, Utah

Utah Cancer Specialists

Salt Lake City, Utah, United States, 84121

United States, Virginia

University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic

Charlottesville, Virginia, United States, 22903

Brazil

Liga Norte Riograndense Contra O Cancer

Natal, Brazil, 59062-000

Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo

Passo Fundo, Brazil, 99010-090

Ministerio da Saude - Instituto Nacional do Cancer

Rio de Janeiro, Brazil, 20230-130

SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo

Sao Paulo, Brazil, 04037-002

Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

Sao Paulo, Brazil, 04039-004

Clinica Sao Germano

São Paulo, Brazil, 01455-010

Czechia

Fakultni nemocnice Brno

Brno, Czechia, 625 00

Fakultni nemocnice Hradec Kralove

Hradec Kralove, Czechia, 500 05

Fakultni nemocnice Ostrava

Ostrava, Czechia, 70852

Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

Praha 2, Czechia, 128 08

France

CHU de Nantes hôtel-Dieu

Nantes Cedex 1, France, 44093

CHU de Bordeaux - Hospital Haut-Leveque

Pessac cedex, France, 33604

Centre hospitalier Lyon-Sud

Pierre-Bénite, France, 69495

CHU Bretonneau

Tours Cedex 9, France, 37044

CHU Nancy Brabois

Vandoeuvre Les Nancy, France, 54511

Germany

Klinikum Chemnitz gGmbH

Chemnitz, Germany, 09113

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany, 20246

Asklepios Klinik Altona

Hamburg, Germany, 22763

Universitaetsklinikum Heidelberg

Heidelberg, Germany, 69120

Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

Tübingen, Germany, 72076

Israel

Rambam Medical Center

Haifa, Israel, 31096

Carmel Medical Center

Haifa, Israel, 3436212

Hadassah Medical Center

Jerusalem, Israel, 9112001

Galilee Medical Center

Nahariya, Israel, 22100

Sheba Medical Center

Ramat Gan, Israel, 52621

Tel-Aviv Sourasky Medical Center

Tel-Aviv, Israel, 64239

Japan

Kanazawa University Hospital

Kanazawa, Japan, 920-8641

Matsuyama Red Cross Hospital

Matsuyama, Japan, 790-8524

Nagoya City University Hospital

Nagoya, Japan, 467-8602

Japanese Red Cross Medical Center

Shibuya, Japan, 150-8935

Spain

Inst. Cat. D'Oncologia-Badalona

Badalona, Spain, 08916

Hosp. Clinic I Provincial de Barcelona

Barcelona, Spain, 08036

Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, Spain, 08908

Hosp. Univ. Vall D Hebron

Barcelona, Spain, 8035

Hosp. Gral. Univ. Gregorio Marañon

Madrid, Spain, 28007

Clinica Univ. De Navarra

Madrid, Spain, 28027

Hosp. Univ. Ramon Y Cajal

Madrid, Spain, 28034

Hosp. Univ. 12 De Octubre

Madrid, Spain, 28041

Hosp. Son Llatzer

Mallorca, Spain, 07198

Clinica Univ. De Navarra

Pamplona, Spain, 31008

Hosp. Clinico Univ. de Salamanca

Salamanca, Spain, 37007

Hosp. Univ. Dr. Peset

Valencia, Spain, 46017

United Kingdom

Heart of England NHS Foundation Trust

Birmingham, United Kingdom, B9 5SS

Royal Bournemouth Hospital

Bournemouth, United Kingdom, BH7 7DW

Kent and Canterbury Hospital

Canterbury, United Kingdom, CT1 3NG

Manchester Royal Infirmary

Manchester, United Kingdom, M13 9WL

Derriford Hospital

Plymouth, United Kingdom, PL6 8DH

Royal Stoke University Hospital

Stoke on Trent, United Kingdom, ST4 6QG

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:

Study Protocol  [PDF] September 30, 2020

Statistical Analysis Plan  [PDF] September 8, 2020

More Information

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT03412565
• Other Study ID Numbers: CR108435; 2017-004203-41 ( EudraCT Number ); 54767414MMY2040 ( Other Identifier: Janssen Research & Development, LLC )
• First Posted: January 26, 2018
• Results First Posted: January 12, 2022
• Last Update Posted: March 15, 2023
• Last Verified: March 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Dexamethasone; Prednisone; Lenalidomide; Bortezomib; Melphalan; Daratumumab; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal