NCT04302324 · REGISTRY CONDITION SEARCH

A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-05-20

This is a single-center, non-randomized, phase 2 study in which patients will receive daratumumab (subcutaneous, SC) in combination with clarithromycin/pomalidomide/dexamethasone (D-ClaPd) until progressive disease (PD) or unacceptable toxicity. This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of clarithromycin/pomalidomide/dexamethasone with daratumumab SC (D-ClaPd) will yield higher Very Good Partial Response (VGPR) rates in relapsed/refractory multiple myeloma patients than historical pomalidomide/dexamethasone treatment.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Very Good Partial Response Rate or Better Within 8 Cycles of Induction Therapy

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outcome · NOT POSTED

Progression-Free Survival

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outcome · POSTED

Complete Response Rate or Better

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outcome · NOT POSTED

Time to Progression

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outcome · NOT POSTED

Time to Next Therapy

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outcome · NOT POSTED

Duration of Response

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outcome · POSTED

Rate of Minimal Residual Disease (MRD) Negativity

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outcome · NOT POSTED

Rate of Improvement in Response During Maintenance Therapy

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outcome · POSTED

Time to Best Response

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outcome · POSTED

Overall Response Rate

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outcome · POSTED

Very Good Partial Response (VGPR) Rate or Better

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outcome · NOT POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Histologically confirmed Multiple Myeloma * Relapsed and/or refractory myeloma defined as follows: Relapse or progressive disease after at least one previous line of therapy which must include prior daratumumab. At least 8 doses of daratumumab in a previous line must be administered either as monotherapy or in combination with a daratumumab-free interval of ≥3 months AND patient may be daratumumab refractory defined as less than a partial remission (PR) achieved on prior daratumumab-based therapy or have exhibited progression within 60 days of receiving daratumumab. If previous therapy was autologous stem cell transplant (SCT), over 3 months must have elapsed after SCT. * Measurable disease as defined by \> 0.5 g/dL serum monoclonal protein, \>0.1 g/dL serum free light chains, \>0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s). * Females of childbearing potential(FCBP) must have a negative serum or urine pregnancy test within 10 - 14 days prior to and again within 24 hours of prescribing pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Able to take aspirin daily * Life expectancy must be greater than 3 months. * Be able to voluntarily sign and understand written informed consent. * Absolute neutrophil count (ANC) ≥750 cells/mm3 (.75 x 109/L) * Platelets count ≥ 50,000/mm3 (50 x 109/L) * Serum SGOT/AST ≤ 2.0 x upper limits of normal * Serum SGPT/ALT \<3.0 x upper limits of normal * Serum creatinine ≤ 2.5 x upper limits of normal * Serum total bilirubin ≤ 1.5 x upper limits of normal (Total bilirubin ≥ 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%) * All participants must be registered into the mandatory POMALYST REMS™ program and be willing and able to comply with the requirements of the POMALYST REMS™ program. Exclusion Criteria: * Prior exposure to non-daratumumab anti-CD38 monoclonal antibodies or pomalidomide. Prior pomalidomide exposure in 1 or more previous lines of therapy allowed if partial remission (PR) or better achieved. No disease progression may have occurred within 60 days of receiving pomalidomide. * New York Heart Association (NYHA) Class III or IV heart failure, unstable cardiac arrhythmia, or unstable angina * Myocardial infarction within the past 6 months * Severe obstructive airway disease * Planned high-dose chemotherapy and autologous stem cell transplantation within 6, 28-day treatment cycles after starting on treatment * Female patients who are lactating or have a positive serum pregnancy test during the screening period * Failure to have fully recovered (ie, ≤ Grade 1 toxicity) from the reversible effects of prior chemotherapy * Major surgery within 14 days before enrollment * Radiotherapy within 14 days before enrollment (if area involved is small than within 7 days) * Systemic treatment, within 14 days before the first dose, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort * Seropositive for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C * Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol * Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent * Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection * Patient has greater than Grade 3 peripheral neuropathy, or Grade 2 pain * Participation in other clinical trials within 30 days * History of thromboembolic event within the past 6 months prior to enrollment
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Induction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond
intervention Names
Drug: Daratumumab SC
Drug: Clarithromycin
Drug: Pomalidomide
Drug: Dexamethasone
label
daratumumab/clarithromycin/pomalidomide/dexamethasone
type
EXPERIMENTAL

interventions

arm Group Labels
daratumumab/clarithromycin/pomalidomide/dexamethasone
description
Given as 1800mg via injection
name
Daratumumab SC
other Names
Faspro
type
DRUG
arm Group Labels
daratumumab/clarithromycin/pomalidomide/dexamethasone
description
Given as 500mg oral capsule
name
Clarithromycin
type
DRUG
arm Group Labels
daratumumab/clarithromycin/pomalidomide/dexamethasone
description
Given as 4mg oral capsule
name
Pomalidomide
type
DRUG
arm Group Labels
daratumumab/clarithromycin/pomalidomide/dexamethasone
description
Given as 20mg IV and 20mg or 40mg oral tablets
name
Dexamethasone
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 11
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Very Good Partial Response or better defined as the number of participants with a documented Very Good Partial Response (VGPR) or better as best response per International Myeloma Working Group (IMWG) criteria, measured from date of enrollment through the end of the 8th induction cycle.
measure
Very Good Partial Response Rate or Better Within 8 Cycles of Induction Therapy
time Frame
up to end of 8th induction cycle (up to approximately 224 days)

secondary Outcomes

description
Progression-Free Survival (PFS) is measured in months from the date of enrollment to the date of disease progression and/or death. Median estimate is calculated using the Kaplan-Meier methodology.
measure
Progression-Free Survival
time Frame
Approximately 3 years
description
The number of participants with a documented Complete Response (CR) or better, per International Myeloma Working Group (IMWG) criteria.
measure
Complete Response Rate or Better
time Frame
Approximately 1 year
description
Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met the criteria for Progressive Disease
measure
Time to Progression
time Frame
Approximately 3 years
description
Measured in months from the date of enrollment to the start date of subsequent treatment for relapsed/refractory multiple myeloma
measure
Time to Next Therapy
time Frame
Approximately 3 years
description
Duration of Response (DoR) is defined as the time between the date of initial documentation of best response to the date of first documented evidence of disease progression.
measure
Duration of Response
time Frame
Approximately 3 years
description
Defined as a number of MRD negative participants
measure
Rate of Minimal Residual Disease (MRD) Negativity
time Frame
Approximately 8 months
description
Percentage of patients that achieved an improved response during maintenance compared to end of induction.
measure
Rate of Improvement in Response During Maintenance Therapy
time Frame
Approximately 3 years
description
Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met criteria for best response per International Myeloma Working Group (IMWG) criteria.
measure
Time to Best Response
time Frame
Approximately 9.5 months
description
The number of participants with a documented Overall Response (Partial Response or better), per International Myeloma Working Group (IMWG) criteria.
measure
Overall Response Rate
time Frame
Approximately 1 year
description
The number of participants with a documented Very Good Partial Response (VGPR) Rate or better, per International Myeloma Working Group (IMWG) criteria.
measure
Very Good Partial Response (VGPR) Rate or Better
time Frame
Approximately 1 year
description
Overall Survival (OS) is measured in months from the date of enrollment to the date of the participant's death. Greenwood's formula will be used to calculate 95% confidence intervals for the Kaplan-Meier survival estimates.
measure
Overall Survival
time Frame
Approximately 5 years

Full study description

brief Summary: This is a single-center, non-randomized, phase 2 study in which patients will receive daratumumab (subcutaneous, SC) in combination with clarithromycin/pomalidomide/dexamethasone (D-ClaPd) until progressive disease (PD) or unacceptable toxicity. This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of clarithromycin/pomalidomide/dexamethasone with daratumumab SC (D-ClaPd) will yield higher Very Good Partial Response (VGPR) rates in relapsed/refractory multiple myeloma patients than historical pomalidomide/dexamethasone treatment.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice