Bortezomib for Multiple Myeloma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Multiple Myeloma+2 MoreBortezomib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a 4-drug combo vs. a 3-drug combo to see if the former is more effective in shrinking cancer or preventing its return.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Time from Step 2 randomization at the start of consolidation to death or to the date last known alive, assessed up to 15 years

Year 2
Best response
Incidence of adverse events
Incidence of grade 3 or higher adverse events
Incidence of grade 3 or higher non-hematologic adverse events
Year 1
FACT-Ntx TOI recovery rate (Patient reported outcome [PRO])
Month 9
Change in Functional Assessment of Cancer Therapy - Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) score (Patient reported outcome)
Year 1
Levels and changes of FACT-General (G) (physical well-being [PWB] + functional well-being [FWB]) score (PRO)
Year 15
Consolidation overall survival
Year 15
Consolidation progression-free survival
Up to 15 years
Comparison of selected PRO-CTCAEs with provider obtained assessment of same CTCAE items (PRO)
PRO completion rate
PRO compliance rate
Presence, frequency, interference, amount and/or severity of select PRO- Common Terminology Criteria for Adverse Events (CTCAEs) (PRO)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Recipient - Chemotherapy Group
100%Hemoglobin (hgb)
90%Nausea
80%Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
80%Neutrophils/granulocytes (ANC/AGC) for BMT
80%SGPT (ALT)
80%Vomiting
80%Injection site reaction
80%Leukocytes (total WBC)
80%SGOT (AST)
70%Creatinine
70%Diarrhea (without colostomy)
70%Neutrophils/granulocytes (ANC/AGC)
70%Lymphopenia
70%Platelets
60%Infection (documented clinically or microbiologically) with Grade 3 or 4 neutropenia
60%Bone pain
60%Rash/desquamation
60%Platelets for BMT
60%Transfusion: Platelets for BMT
60%Infection without neutropenia
60%Fatigue (asthenia, lethargy, malaise)
60%Hypomagnesemia
60%Transfusion: pRBCs for BMT
60%Hyponatremia
50%Cough
50%Neuropathy-sensory
50%Hypoxia
40%Leukocytes (total WBC) for BMT
40%Catheter-related infection
40%Pain - Other
40%Dyspnea (shortness of breath)
40%Hypoalbuminemia
40%Hypocalcemia
40%Stomatitis/pharyngitis (oral/pharyngeal mucositis)
40%Bilirubin
30%Febrile neutropenia
30%Hypotension
30%Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
30%Hypophosphatemia
30%Hyperglycemia
30%Constipation
30%Alkaline phosphatase
30%Transfusion: pRBCs
30%Diarrhea for BMT
30%Anorexia
20%Rigors/chills
20%Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
20%Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
20%Chest pain (non-cardiac and non-pleuritic)
20%Hypertension
20%Metabolic-Other (Hyperbilirubinemia; hyperbilirubinemia r/t GVH)
20%Sweating (diaphoresis)
20%Urinary frequency/urgency
20%Abdominal pain or cramping
20%Edema
20%Hypokalemia
20%Rash/desquamation for BMT
20%Flushing
10%Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
10%Injection site reaction, bilat legs
10%Mood alteration::Depression
10%Transfusion: Platelets
10%Acidosis (metabolic or respiratory)
10%Dizziness/lightheadedness
10%Infection w/out neutropenia, catheter related
10%Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT
10%Joint, muscle, or bone (osseous)- Other (Calf cramping)
10%Pulmonary-Other (URI)
10%Pleural effusion (non-malignant)
10%Proteinuria
10%Rectal bleeding/hematochezia
10%Salivary gland changes
10%Weight loss
10%Allergic reaction/hypersensitivity (including drug fever)
10%Constitutional Symptoms-Other (CGVHD-skin)
10%Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis
10%Hemoptysis
10%Infection without neutropenia, wound
10%Infection without neutropenia, blood
10%Hypothyroidism
10%Infection without neutropenia, C-diff
10%Infection: blood
10%Infection without neutropenia, Nasal Pharynx
10%Insomnia
10%Injection site reaction, bilat arms
10%Lymphatics-Other (Adenopathy)
10%Lymphatics
10%Thrombosis/embolism
10%Skin-Other (Drug reaction face, hands, neck)
10%Vasovagal episode
10%Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)
10%Neuropathic pain
10%Nausea and vomiting
10%Myalgia (muscle ache)
10%Pruritus
10%Dyspareunia
10%Mood alteration-euphoria
10%Pericardial effusion/pericarditis
10%Pigmentation changes (e.g., vitiligo)
10%Pneumonitis/pulmonary infiltrates
10%Metabolic-Other (GGT)
10%Amylase
10%Allergy - Other (Transfusion reaction (platelets)
10%Diarrhea
10%Headache
10%Ileus (or neuroconstipation)
10%Mood alteration-depression
10%Ocular-Other (Ocular cGVHD)
10%Cataract
10%Neurologic-Other (Neuropathy)
10%Bilirubin - graft versus host disease (GVHD)
10%Taste disturbance (dysgeusia)
10%Hypermagnesemia
10%Infection, Other (Upper respiratory infection (URI))
10%Diarrhea (without colostomy) BMT
10%Diarrhea (with colostomy)
This histogram enumerates side effects from a completed 2008 Phase 2 trial (NCT00006184) in the Recipient - Chemotherapy Group ARM group. Side effects include: Hemoglobin (hgb) with 100%, Nausea with 90%, Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) with 80%, Neutrophils/granulocytes (ANC/AGC) for BMT with 80%, SGPT (ALT) with 80%.

Trial Design

3 Treatment Groups

Arm C (daratumumab, lenalidomide, dexamethasone)
1 of 3
Arm A (daratumumab, lenalidomide, dexamethasone)
1 of 3
Arm B (bortezomib, daratumumab, lenalidomide, dexamethasone)
1 of 3

Active Control

Experimental Treatment

1450 Total Participants · 3 Treatment Groups

Primary Treatment: Bortezomib · No Placebo Group · Phase 3

Arm B (bortezomib, daratumumab, lenalidomide, dexamethasone)Experimental Group · 5 Interventions: Dexamethasone, Daratumumab and Hyaluronidase-fihj, Lenalidomide, Quality-of-Life Assessment, Bortezomib · Intervention Types: Drug, Biological, Drug, Other, Drug
Arm C (daratumumab, lenalidomide, dexamethasone)ActiveComparator Group · 4 Interventions: Dexamethasone, Daratumumab and Hyaluronidase-fihj, Lenalidomide, Quality-of-Life Assessment · Intervention Types: Drug, Biological, Drug, Other
Arm A (daratumumab, lenalidomide, dexamethasone)ActiveComparator Group · 4 Interventions: Dexamethasone, Daratumumab and Hyaluronidase-fihj, Lenalidomide, Quality-of-Life Assessment · Intervention Types: Drug, Biological, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Lenalidomide
FDA approved
Bortezomib D-mannitol
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time from step 2 randomization at the start of consolidation to death or to the date last known alive, assessed up to 15 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,073 Previous Clinical Trials
41,137,468 Total Patients Enrolled
556 Trials studying Multiple Myeloma
191,756 Patients Enrolled for Multiple Myeloma
ECOG-ACRIN Cancer Research GroupLead Sponsor
103 Previous Clinical Trials
170,585 Total Patients Enrolled
3 Trials studying Multiple Myeloma
1,975 Patients Enrolled for Multiple Myeloma
Shaji K KumarPrincipal InvestigatorECOG-ACRIN Cancer Research Group
5 Previous Clinical Trials
705 Total Patients Enrolled
5 Trials studying Multiple Myeloma
705 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patient must have an ECOG PS of 0-2 (PS 3 allowed if secondary to pain).
You must meet all eligibility criteria in STEP 0 with exception of allergy requirement.
You have beta2 microglobulin, albumin and lactate dehydrogenase levels of greater than 0.5 g/dL, 0.5 g/dL and 1.5 mmol/L, respectively.
Patient must have newly diagnosed MM by IMWG criteria.
Patient must be able to undergo diagnostic bone marrow aspirate following preregistration.
Bone marrow aspirate specimen must be submitted to Adaptive Biotechnologies for clonoSEQ Assay.

Who else is applying?

What state do they live in?
Ohio50.0%
Minnesota50.0%
How old are they?
65+100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%