Trial · NCT06948084

Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse

NCT06948084, Phase 2, Recruiting, National Cancer Institute (NCI)

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse. Trials, record NCT06948084. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06948084

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse
NCT number: NCT06948084
Status: Recruiting
Phases: Phase 2
Enrollment: 80 participants, estimated
Lead sponsor: National Cancer Institute (NCI)
Conditions: Recurrent Multiple Myeloma, Refractory Multiple Myeloma
Interventions: Biospecimen Collection, Bone Marrow Biopsy, Carfilzomib, Computed Tomography, Daratumumab and Recombinant Human Hyaluronidase, Dexamethasone, FDG-Positron Emission Tomography, Pomalidomide, Teclistamab
First posted: 2025-04-29
Last updated: 2026-11-04

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Minimal residual disease (MRD) negativity	After 6 cycles of treatment (cycle length = 28 days), assessed at 6 months	Will be determined by the Adaptive Biotechnologies clonoSEQ assay result. Analysis will be performed using Cochran-Mantel-Haenszel (CMH) test, stratified on prior anti-CD38 antibody therapy and investigator's choice of therapy if assigned to Arm A. MRD-negative status requires both MRD negativity and achievement of complete response. Will be summarized using descriptive statistics by treatment arm with two-sided exact binomial 80% confidence intervals (CI), Clopper-Pearson. The corresponding CMH odds ratio (OR) estimate with an 80% CI, and p-value will be reported. Logistic regression will be used to assess the treatment effect within subgroups including but not limited to age 70 status, prior anti-CD38 antibody therapy and high-risk by fluorescence in situ hybridization status.
Secondary	Incidence of adverse events (AEs)	Up to 6 cycles (cycle length = 28 days) and overall assessed up to 10 years	Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) and classified by Medical Dictionary for Regulatory Activities (MedDRA) system organ class. Maximum grade toxicity by AE type will be tabulated. Summaries (count and percentages) will be reported by AE type by arm.
Secondary	Incidence of grade 3 or higher hematologic and/or non-hematologic AEs	Up to 6 cycles (cycle length = 28 days) and overall assessed up to 10 years	Will be graded according to the NCI CTCAE and classified by MedDRA system organ class. Maximum grade toxicity by AE type will be tabulated. Summaries (count and percentages) will be reported by AE type by arm. Rates of maximum grade 3 or higher (including grade 5) non-hematologic, hematologic and overall toxicity will be calculated along with 90% CIs. AEs will be further analyzed by arm in subsets of serious AEs per protocol, lethal AEs and treatment-emergent AEs status.
Secondary	Progression-free survival (PFS)	From randomization until the earlier of progression or death due to any cause, assessed up to 10 years	PFS will be estimated in the treated population using the Kaplan-Meier method and compared between arms using the stratified log-rank test. Stratified cox proportional hazards (PH) regression will be used to produce the treatment hazard ratio (HR) along with the 90% CI, provided PH assumption is valid. Sensitivity analyses excluding untreated patients will be conducted.
Secondary	Overall survival (OS)	From randomization to death due to any cause, assessed up to 10 years	OS will be estimated in the treated population using the Kaplan-Meier method and compared between arms using the stratified log-rank test. Stratified cox PH regression will be used to produce the treatment HR along with the 90% CI, provided PH assumption is valid. Sensitivity analyses excluding untreated patients will be conducted.
Secondary	Response rates	After 6 cycles of treatment (cycle length = 28 days) and overall, assessed up to 10 years	Will be reported by treatment arm. Rates of stringent complete response (CR) or better, very good partial response (VGPR) or better and partial response (PR) or better will be computed along with 90% CIs in all treated patients. Stratified CMH test will be used to test the difference in VGPR or better rates between arms. Sensitivity analyses excluding untreated patients will be conducted.
Other	Event-free survival	From randomization until the earlier of non-protocol therapy, progression, or death due to any cause, assessed up to 10 years
Other	Time to progression	From randomization to time of documented progression or censored at date of last disease evaluation if alive or death not due to disease progression, assessed up to 10 years
Other	Duration of treatment	From randomization to treatment end, or censored at the date of last treatment, assessed up to 10 years
Other	Cumulative dose intensity	Up to 24 months (cycle length = 28 days)	Will be defined as the sum of all doses taken across all cycles. Will be characterized using descriptive statistics.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA180820	ECOG-ACRIN Network Group Operations Center	ODwyer, Peter J; SCHNALL, MITCHELL D.	ECOG-ACRIN MEDICAL RESEARCH FOUNDATION	NATIONAL CANCER INSTITUTE	2014 to 2026

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06948084

GET https://conductscience.org/api/trials/v1/NCT06948084/registered

API reference For AI assistants