---
title: A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma
nct_id: NCT05243342
overall_status: COMPLETED
phase: PHASE1
sponsor: Genentech, Inc.
study_type: INTERVENTIONAL
primary_condition: Multiple Myeloma
countries: Australia, Denmark, Norway, Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05243342.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05243342"
ct_last_update_post_date: 2025-02-17
last_seen_at: "2026-05-12T06:17:41.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma

**Official Title:** A Phase Ib, Open-Label, Multicenter, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Patients With Relapsed/Refractory Multiple Myeloma

**NCT ID:** [NCT05243342](https://clinicaltrials.gov/study/NCT05243342)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 18
- **Lead Sponsor:** Genentech, Inc.
- **Conditions:** Multiple Myeloma
- **Start Date:** 2022-04-28
- **Completion Date:** 2024-07-10
- **CT.gov Last Update:** 2025-02-17

## Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with a multiple myeloma (MM)-targeting monoclonal antibody capable of inducing antibody-dependent cellular toxicity (ADCC) in participants with relapsed or refractory (R/R) MM who have received a minimum of three prior treatments, including at least one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one anti-CD38 monoclonal antibody.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Life expectancy of at least 12 weeks
* Measurable disease, as defined by the protocol
* Participants must have received a minimum of 3 prior lines of therapy, including at least one PI, one IMiD, and an anti-CD38 monoclonal antibody
* Best response of stable disease or better with at least one prior anti-CD38 monoclonal antibody containing line of treatment

Exclusion Criteria:

* Any anti-cancer therapy within 3 weeks prior to initiation of study treatment, with exceptions defined by the protocol
* Prior allogeneic stem cell or solid organ transplantation
* Autologous stem cell transplantation within 100 days prior to initiation of study treatment
* Significant cardiovascular disease
* Known clinically significant liver disease
* Active or history of autoimmune disease or immune deficiency
* Known active infection requiring IV anti-microbial therapy within 14 days prior to first study drug administration
* Primary or secondary plasma cell leukemia
* Current CNS involvement by MM
* Other protocol defined inclusion/exclusion criteria may apply
```

## Arms

- **Dose escalation** (EXPERIMENTAL) — Participants will receive escalating doses of XmAb24306 with daratumumab up to the maximum tolerated dose (MTD)
- **Dose expansion** (EXPERIMENTAL) — Participants will receive XmAb24306 with daratumumab at the recommended phase 2 dose (RP2D)

## Interventions

- **XmAb24306** (DRUG) — XmAb24306 will be given via intravenous (IV) infusion
- **Daratumumab** (DRUG) — Participants will receive daratumumab via subcutaneous (SC) injection every week for Cycles 1-4, every 2 weeks for Cycles 5-12, and every 4 weeks thereafter (cycle length = 2 weeks for Cycles 1-12 and 4 weeks thereafter)

## Primary Outcomes

- **Percentage of participants with adverse events (AEs)** _(time frame: Up to approximately 3 years)_

## Secondary Outcomes

- **Serum concentration of XmAb24306** _(time frame: Baseline to approximately 3 years)_
- **Objective response rate (ORR)** _(time frame: Baseline to approximately 3 years)_
- **Prevalence of XmAb24306 anti-drug antibodies (ADAs)** _(time frame: Baseline to approximately 3 years)_
- **Incidence of XmAb24306 ADAs** _(time frame: Baseline to approximately 3 years)_

## Locations (7)

- Royal Adelaide Hospital, Adelaide, South Australia, Australia
- Alfred Hospital, Melbourne, Victoria, Australia
- Odense Universitetshospital, Odense C, Region Syddanmark, Denmark
- Sygehus Lillebælt, Vejle, Vejle, Region Syddanmark, Denmark
- Oslo Universitetssykehus HF, Oslo, Norway
- Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, Spain
- Hospital Universitari Vall d'Hebron, Barcelona, Spain

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.royal adelaide hospital|adelaide|south australia|australia` — added _(2026-05-12)_
- `locations.alfred hospital|melbourne|victoria|australia` — added _(2026-05-12)_
- `locations.odense universitetshospital|odense c|region syddanmark|denmark` — added _(2026-05-12)_
- `locations.sygehus lillebælt, vejle|vejle|region syddanmark|denmark` — added _(2026-05-12)_
- `locations.oslo universitetssykehus hf|oslo||norway` — added _(2026-05-12)_
- `locations.hospital universitario germans trias i pujol|badalona|barcelona|spain` — added _(2026-05-12)_
- `locations.hospital universitari vall d'hebron|barcelona||spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05243342.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05243342*  
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