In the latest edition of our Guidelines+ Trials Rundown Series, we delve into the most recent research and clinical trials focusing on multiple myeloma (MM) in adults.
The following list has been carefully curated by evaluating the ongoing Phase 3 trials for MM, specifically targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 6 months and have results.
This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.
Without further ado, let us explore the list of Multiple Myeloma Clinical Trials!
Quick View Table of Multiple Myeloma Clinical Trials
Multiple Myeloma Clinical Trials:
Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
- Sponsor: GlaxoSmithKline
- This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.
- Interventions: DRUG: Belantamab mafodotin, DRUG: Pom/dex (Pomalidomide plus low dose Dexamethasone)
- Primary Outcomes Measures: Progression-free Survival (PFS) Based on Investigator-assessed Response as Per International Myeloma Working Group (IMWG), PFS is time from randomization until earliest date of progressive disease (PD), or death due to any cause per investigator-assessed response per IMWG. PD is 25% increase from nadir in any of following: serum M-protein (absolute increase 0.5 gram per deciliter \[g/dL\]),urine M-protein(absolute increase 200 mg/24hr),difference between involved/uninvolved FLC levels (absolute increase \>10 mg/dL) in patients without measurable serum and urine M-protein levels, or bone marrow plasma-cell percentage irrespective of baseline status (absolute increase 10%) in patients without measurable serum and urine M-protein levels and without measurable involved FLC levels; appearance of new lesion, 50% increase in longest diameter of a lesion previously measured \>1cm in short axis, or 50% increase from nadir in sum of products of two longest perpendicular diameters of more than 1 lesion; 50% increase in circulating plasma cells (minimum of 200 cells/microliter) if this is only measure of disease., Up to 27 months.
Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
- Sponsor: Janssen Research & Development, LLC
- The purpose of this study is to assess the effects of administration of daratumumab when combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and dexamethasone alone, for participants with relapsed or refractory multiple myeloma.
- Interventions: DRUG: Daratumumab, DRUG: VELCADE (Bortezomib), DRUG: Dexamethasone
- Primary Outcomes Measures: Progression-free Survival (PFS), PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (\>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 gram per deciliter (g/dL); Increase of \>=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be \>10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new 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., From the date of randomization to either progressive disease or death, whichever occurred first (approximately 1 year 4 months).
A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
- Sponsor: Janssen Research & Development, LLC
- The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.
- Interventions: DRUG: Daratumumab, DRUG: Lenalidomide, DRUG: Dexamethasone
- Primary Outcomes Measures: Progression-free Survival (PFS), PFS: duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD: defined as meeting any 1 of following criteria: Increase of greater than equal to (\>=)25 percent(%) in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 gram per deciliter (g/dL); Increase of \>=25% in 24-hours(h) urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24h; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be \>10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) attributed solely to plasma cell (PC) proliferative disorder., From randomization to either disease progression or death whichever occurs first (up to 21 months).
A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma
- Sponsor: Janssen Research & Development, LLC
- The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).
- Interventions: DRUG: Dara SC, DRUG: Dara IV
- Primary Outcomes Measures: Overall Response Rate (ORR), ORR was defined as the percentage of participants who achieved partial response (PR) or better according to International Myeloma Working Group (IMWG) criteria, during or after study treatment. 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)/24 hours, If the serum and urine M-proteins are not measurable, a decrease of \>=50% in the difference between involved and uninvolved free light chain (FLC) levels were required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, \>=50% reduction in bone marrow plasma cells (PCs) was 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 was also required., Up to 1 year 8 months. Maximum Trough Concentration (Ctrough) of Daratumumab, Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1., Predose on Cycle 3 Day 1 (each cycle of 28 days) plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) attributed solely to plasma cell (PC) proliferative disorder., From randomization to either disease progression or death whichever occurs first (up to 21 months).
A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma
- Sponsor: Janssen Research & Development, LLC
- The purpose of this study is to determine if the addition of daratumumab to velcade (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared with VMP alone in participants with previously untreated multiple myeloma who are ineligible for high dose chemotherapy and autologous stem cell transplant (ASCT).
- Interventions: DRUG: Velcade, DRUG: Melphalan, DRUG: Prednisone, DRUG: Daratumumab IV, DRUG: Dexamethasone, DRUG: Daratumumab SC
- Primary Outcomes Measures: Progression Free Survival (PFS), PFS- duration from date of randomization to Progressive disease (PD)/death, whichever occurs first. PD per IMWG criteria-Increase of 25% from lowest response value in one of following: Serum and urine M-component (absolute increase \>=0.5 gram per deciliter \[g/dL\] and \>=200 milligram \[mg\]/24 hours respectively); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase\>10 mg/dL); Only participants without measurable serum and urine M-protein levels, without measurable disease by FLC levels, bone marrow Plasma cells (PC) %(absolute % \>=10%);Bone marrow PC%: absolute% \>10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the PC proliferative disorder., From randomization to either disease progression or death whichever occurs first (up to 2.4 years).
Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
- Sponsor: National Cancer Institute (NCI)
- This randomized phase III trial studies melphalan and prednisone with thalidomide to see how well it works compared to melphalan and prednisone together with lenalidomide in treating patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as melphalan and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Thalidomide and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It is not yet known whether melphalan and prednisone are more effective when given together with thalidomide or lenalidomide in treating multiple myeloma.
- Interventions: OTHER: Laboratory Biomarker Analysis, DRUG: Lenalidomide, DRUG: Melphalan, DRUG: Prednisone, OTHER: Quality-of-Life Assessment, DRUG: Thalidomide
- Primary Outcomes Measures: Progression-Free Survival (PFS), PFS is defined as the time from randomization to the earlier of progression or death of any cause., Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.
Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma
- Sponsor: Amgen
- Compare carfizomib, dexamethasone, and daratumumab (KdD) to Carfilzomib and dexamethasone (Kd) in terms of progression free survival (PFS) in participants with multiple myeloma who have relapsed after 1 to 3 prior therapies.
- Interventions: DRUG: Dexamethasone, DRUG: Daratumumab, DRUG: Carfilzomib
- Primary Outcomes Measures: Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only), Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC). The duration of PFS was right censored for participants who met any of the following conditions: 1. no baseline/post-baseline disease assessments; 2. started a new anti myeloma therapy before documentation of progressive disease or death; 3. progressive disease or death immediately after more than 70 days without disease assessment visit or; 4. alive without documentation of disease progression before the analysis trigger date (PA DCO); 5. lost to follow-up or withdrawn consent., From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks.
Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
- Sponsor: National Cancer Institute (NCI)
- This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient’s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient’s blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma.
- Interventions: PROCEDURE: Autologous Hematopoietic Stem Cell Transplantation, OTHER: Laboratory Biomarker Analysis, DRUG: Lenalidomide, DRUG: Melphalan, PROCEDURE: Peripheral Blood Stem Cell Transplantation, OTHER: Placebo Administration
- Primary Outcomes Measures: “Time to Progression, Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progression was defined per the International Myeloma Working Group definition as one more of the following: * 25% increase in serum M-component (absolute increase \>= 0.5g/dl) * 25% increase in urine M-component (absolute increase \>= 200mg/24hour * 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl) * 25 % increase in bone marrow plasma cell percentage (absolute increase of \>=10%) * Definite development of new bone lesion or soft tissue plasmacytomas* Development of hypercalcemia, Duration of study (up to 10years)”
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
- Sponsor: Sanofi
- The purpose of this study is to compare the efficacy of isatuximab when combined to carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple myeloma already treated with 1 to 3 prior lines of therapy.
- Interventions: DRUG: isatuximab SAR650984|DRUG: carfilzomib|DRUG: dexamethasone
- Primary Outcomes Measures: ORR was defined as the percentage of participants who achieved partial response (PR) or better according to International Myeloma Working Group (IMWG) criteria, during or after study treatment. 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)/24 hours, If the serum and urine M-proteins are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels were required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, >=50% reduction in bone marrow plasma cells (PCs) was 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 was also required. The other primary outcome measurement Maximum Trough Concentration (Ctrough) of Daratumumab, defined as the serum predose concentration of daratumumab on Cycle 3 Day 1.
Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma
- Sponsor: National Cancer Institute (NCI)
- This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.
- Interventions: DRUG: Dexamethasone, OTHER: Laboratory Biomarker Analysis, DRUG: Lenalidomide, DRUG: Thalidomide
- Primary Outcomes Measures: “Proportion of Patients With Objective Response (First Phase, Step 1), Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response). As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only., Assessed every 4 weeks for 16 weeks during Step 1”.
Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma
- Sponsor: National Cancer Institute (NCI)
- This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.
- Interventions: DRUG: Bortezomib, DRUG: Dexamethasone, OTHER: Laboratory Biomarker Analysis, DRUG: Lenalidomide
- Primary Outcomes Measures: Progression-free Survival, Unstratified median progression-free survival in months., From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years.
A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
- Sponsor: Amgen
- Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy.
- Interventions: DRUG: Carfilzomib, DRUG: Carfilzomib, DRUG: Lenalidomide, DRUG: Dexamethasone
- Primary Outcomes Measures: Overall Response Rate (ORR) Per International Myeloma Working Group Uniform Response Criteria (IMWG-URC), ORR was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-hours). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hours urinary M-protein by ≥ 90% or to \< 200 mg/24-hours. The ORR 95% confidence intervals (CIs) were estimated using the Clopper-Pearson method., Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks.
Potential Guideline That May Be Affected Includes:
- Immunotherapy for the Treatment of Multiple Myeloma
- Society for Immunotherapy of Cancer
- Publication: July 12, 2020
- Role of Bone-Modifying Agents in Multiple Myeloma
- American Society of Clinical Oncology
- Publication: January 17, 2018
This is it – a list of Phase 3 Clinical Trials for Multiple Myeloma as of July 2024. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.